ThalassemiaPhase 2NCT05355766
Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients
A Phase 2 study testing CN128 Tablets in people with Thalassemia and Iron Overload, run by Hangzhou Zede Pharma-Tech Co., Ltd. at 1 site in China.
Trial summary
The safety and efficacy of CN128 is studied in thalassaemia with sever liver iron overloaded patients. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Thalassemia, Iron Overload
- What is being tested?
- CN128 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2022to 6 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Thalassemia patients.
- The number of blood transfusion per month ≥1. Or hemoglobin can not be maintained at 90g/L above, if blood transfusions is less than once per month.
- Severe iron overloaded patients (serum ferritin>2500 µg/L or liver iron concentration (LIC)>15 mg/g dw) despite prior treatment with at least one iron chelator.
- Patients aged 16 and above.
- Volunteer for the trial and sign the informed consent.
Who cannot join
- Active hepatitis B (HBsAg positive, HBsAb negative) or hepatitis C (HCV antibody positive, detectable HCV RNA, and Alkaline Phosphatase (ALT) beyond normal range)
- Active gastrointestinal disease history (including: gastric ulcer, duodenal ulcer, stomach or esophageal varices, ulcerative colitis, Crohn's disease, gastrointestinal cancer, familial genetic multiple intestinal polyps), and History of gastrointestinal perforation, gastrointestinal surgery that influence drug absorption, and other potential intestinal complications considered by researchers.
- ALT or Aspartate Aminotransferase (AST) > 2.5 × upper limit of normal (ULN), or serum creatinine > 1.5 × ULN.
- Neutropenia patient (neutrophil count < 1.5 × 10^9 / L).
- Active infection uncontrolled.
- Autoimmune hemolytic anemia patients.
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- The patients who are currently taking CYP3A strong inducer or strong inhibitor drugs, or the drug that may extend the QT interval, or the drug that may decrease neutrophil count, but can not temporarily interrupt the use of such drugs.
- Cardiac iron overloaded patients, cardiac magnetic resonance MRI T2*<10 ms
- The patients who are allergic or contraindicated to the main ingredients or excipients of CN128 tablets.
- Congenital long QT syndrome or known family history of long QT syndrome, QTc interval>480 ms, clinically significant ventricular or atrial fast arrhythmia.
- The patients who can not accept MRI as detection means, such as claustrophobic for MRI, pacemaker, and those using ferromagnetic metal implants.
- Birth planner (including male subjects) within or within 3 months after the end of the trial.
- Participated in other clinical trials in the four weeks before taking the test preparation, except for non-interventional studies.
- Pregnant or lactating women.
- Unsuitable to participate in the trial considered by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital Of Guangxi Medical University
Nanning, Guangxi
About this study
Official title: Phase IIb Clinical Study to Assess the Safety and Efficacy of CN128 Tablets in the Treatment of Iron Overload in Transfusion Dependent Thalassemia With Sever Liver Iron Overloaded Patients Aged 16 and Above
The safety and efficacy of CN128 is studied in thalassaemia with sever liver iron overloaded patients.
Read the detailed description
- The study is designed as a single arm and opened phase IIb clinical trial, so as to investigate the safety and efficacy of CN128.
- A total of 50 eligible subjects are planned to be enrolled, and orally administration of CN128 for 52 weeks according to the administration plan.
- Administration plan:
The trial will start with the lower dose of CN128 (10 mg/kg body weight [bw], bid) for one week. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 15 mg/kg body weight [bw], bid for one week. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 20 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 25 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 30 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 30 mg/kg body weight [bw], bid to Week 52. Dosage will be adjusted according to subject status and study plan.
- Conditions
- Thalassemia, Iron Overload
- Being tested
- CN128 Tablets
- Medical subject headings
- Thalassemia, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CN128 TabletsDrug
Also called CN128
Iron chelator, oral tablets
| Study group | Role | What they receive |
|---|---|---|
| CN128 Group | Experimental | All subjects will be given the lower (10 mg/kg bw, bid) to higher dose (30 mg/kg bw, bid) for 52 weeks, according to the administration plan.
The dosage form is tablets. Receives: Drug: CN128 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events, adverse reactions, severe adverse events and severe adverse reactions as a measure of safety and tolerability during the study period.
To determine the incidence, type and severity of adverse events, adverse reactions, severe adverse events and severe adverse reactions in patients up to 52 weeks.
Measured: Up to 52 weeks
Absolute Change in Weight (Unit: kg) From Baseline Over Time
The patient's weight will be determined, and it's one kind of Physical examination.
Measured: Baseline, 26, 39 and 52 weeks.
Absolute Change in Height (Unit: m) From Baseline Over Time
The patient's height will be determined, and it's one kind of Physical examination.
Measured: Baseline, 26, 39 and 52 weeks.
Absolute Change in Temperature (Unit: ℃）From Baseline Over Time
The patient's temperature will be determined, and it's one kind of vital signs checks.
Measured: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Blood pressure (Unit: mmHg ) From Baseline Over Time
Both patient's systolic and diastolic blood pressure will be measured, and it's one kind of vital signs checks.
Measured: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Heart rate (Unit: bpm) From Baseline Over Time
The patient's heart rate will be determined, and it's one kind of vital signs checks.
Measured: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Respiration (Unit: bpm) From Baseline Over Time
The patient's respiration will be determined, and it's one kind of vital signs checks.
Measured: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Absolute Change in Electrocardiogram (P-R (Unit: ms), QRS (Unit: ms), QTc interval (Unit: ms), etc) From Baseline Over Time
The patient's electrocardiogram will be measured, and it's one kind of laboratory test.
Measured: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Change in Auditory Function From Baseline Over Time
The patient's auditory function will be determined by otorhinolaryngology.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in White Blood Count (Unit: 10^9/L) From Baseline Over Time
The patient's white blood count will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Neutrophil Count (Unit: 10^9/L) From Baseline Over Time
The patient's neutrophil count will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Lymphocyte Count (Unit: 10^9/L) From Baseline Over Time
The patient's lymphocyte count will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Monocyte Count (Unit: 10^9/L) From Baseline Over Time
The patient's monocyte count will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Eosinophilic Count (Unit: 10^9/L) From Baseline Over Time
The patient's eosinophilic count will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Basophilic Count (Unit: 10^9/L) From Baseline Over Time
The patient's basophilic count will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Red Blood Count (Unit: 10^9/L) From Baseline Over Time
The patient's red blood count will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Hemoglobin (Unit: g/L) From Baseline Over Time
The patient's hemoglobin will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Hematocrit (Unit:%) From Baseline Over Time
The patient's hematocrit will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Blood Platelet Count (Unit: 10^9/L) From Baseline Over Time
The patient's blood platelet count will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Thrombocytocrit (Unit: %) From Baseline Over Time
The patient's thrombocytocrit will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Alanine Aminotransferase (Unit: U/L) From Baseline Over Time
The patient's alanine aminotransferase will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Bilirubin (Unit:µmol/L) From Baseline Over Time
The patient's total bilirubin will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Protein (Unit:g/L) From Baseline Over Time
The patient's total protein will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Albumin (Unit: g/L) From Baseline Over Time
The patient's albumin will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Globulin (Unit: g/L) From Baseline Over Time
The patient's globulin will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Alkaline Phosphatase (Unit: U/L) From Baseline Over Time
The patient's alkaline phosphatase will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Aspartate Aminotransferase (Unit: U/L) From Baseline Over Time
The patient's aspartate aminotransferase will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Lactate Dehydrogenase (Unit: IU/L) From Baseline Over Time
The patient's lactate dehydrogenase will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Urea (Unit: mmol/L) From Baseline Over Time
The patient's urea will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Creatinine (Unit:µmol/L) From Baseline Over Time
The patient's creatinine will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Glucose (Unit: mmol/L) From Baseline Over Time [ Time
The patient's glucose will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Potassium (Unit: mmol/L) From Baseline Over Time
The patient's potassium will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Sodium (Unit: mmol/L) From Baseline Over Time
The patient's sodium will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Chlorine (Unit: mmol/L) From Baseline Over Time
The patient's chlorine will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Calcium (Unit: mmol/L) From Baseline Over Time
The patient's calcium will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Fibrinogen (Unit: g/L) From Baseline Over Time
The patient's fibrinogen will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Prothrombin time (Unit: s) From Baseline Over Time
The patient's prothrombin time will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Activated Partial Thromboplastin Time (APTT, Unit: s) From Baseline Over Time
The patient's APTT will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Serum Total Thyroxine (Unit: nmol/L) From Baseline Over Time
The patient's serum total thyroxine will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Parathyroid Hormone (Unit: pg/mL) From Baseline Over Time
The patient's parathyroid hormone will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Triiodothyronine (Unit: nmol/L) From Baseline Over Time
The patient's total triiodothyronine will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Thyrotropin (Unit: mIU/L) From Baseline Over Time
The patient's thyrotropin will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Urine Glucose (Unit: mmol/L) From Baseline Over Time
The patient's urine glucose will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Urine Protein (Unit: g/L)) From Baseline Over Time
The patient's urine protein will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 12, 26, 39 and 52 weeks.
Absolute Change in Total Testosterone (Unit: ng/ml) in men From Baseline Over Time
The patient's total testosterone will be determined in men, and it's one kind of laboratory test.
Measured: Baseline, 26, 39 and 52 weeks.
Absolute Change in Free Testosterone (Unit: nmol/L) in men From Baseline Over Time
The patient's free testosterone will be determined in men, and it's one kind of laboratory test.
Measured: Baseline, 26, 39 and 52 weeks.
Absolute Change in Follicle-generating Hormone (Unit: mIU/mL) in women From Baseline Over Time
The patient's follicle-generating hormone will be determined in women, and it's one kind of laboratory test.
Measured: Baseline, 26, 39 and 52 weeks.
Absolute Change in Luteinizing Hormon (Unit: mIU/mL) in women From Baseline Over Time
The patient's luteinizing hormonwill be determined in women, and it's one kind of laboratory test.
Measured: Baseline, 26, 39 and 52 weeks.
Secondary outcomes (2)
Absolute Change in Liver iron content (Unit: mg/g dw) From Baseline Over Time
Liver iron content will be determined by liver magnetic resonance.
Measured: Baseline, 12, 26,39 and 52 weeks.
Absolute Change in Serum ferritin (Unit: µg/L) From Baseline Over Time
Serum ferritin will be determined, and it's one kind of laboratory test.
Measured: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start13 Jun 2022
- Primary completion23 Sep 2024
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Zede Pharma-Tech Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianmin Luo, PhD, Principal investigator, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355766
- Sponsor's protocol ID
- A160605-202
- Status last verified
- Mar 2025
- First submitted
- 22 Apr 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Clinical Study to Assess the Safety and Efficacy of CN128 Tablets in the Treatment of Iron Overload in Transfusion Dependent Thalassemia With Sever Liver Iron Overloaded Patients Aged 16 and Above
- ClinicalTrials.gov ID
- NCT05355766
- Acronym / sponsor ID
- A160605-202
- Conditions
- Thalassemia, Iron Overload
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hangzhou Zede Pharma-Tech Co., Ltd.University, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy of CN128 is studied in thalassaemia with sever liver iron overloaded patients.
Detailed description
- The study is designed as a single arm and opened phase IIb clinical trial, so as to investigate the safety and efficacy of CN128.
- A total of 50 eligible subjects are planned to be enrolled, and orally administration of CN128 for 52 weeks according to the administration plan.
- Administration plan:
The trial will start with the lower dose of CN128 (10 mg/kg body weight [bw], bid) for one week. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 15 mg/kg body weight [bw], bid for one week. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 20 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 25 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 30 mg/kg body weight [bw], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 30 mg/kg body weight [bw], bid to Week 52. Dosage will be adjusted according to subject status and study plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CN128 Group | Experimental | Drug: CN128 TabletsAll subjects will be given the lower (10 mg/kg bw, bid) to higher dose (30 mg/kg bw, bid) for 52 weeks, according to the administration plan. The dosage form is tablets. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Thalassemia patients.
- The number of blood transfusion per month ≥1. Or hemoglobin can not be maintained at 90g/L above, if blood transfusions is less than once per month.
- Severe iron overloaded patients (serum ferritin>2500 µg/L or liver iron concentration (LIC)>15 mg/g dw) despite prior treatment with at least one iron chelator.
- Patients aged 16 and above.
- Volunteer for the trial and sign the informed consent.
Key exclusion criteria (15 listed)
- Active hepatitis B (HBsAg positive, HBsAb negative) or hepatitis C (HCV antibody positive, detectable HCV RNA, and Alkaline Phosphatase (ALT) beyond normal range)
- Active gastrointestinal disease history (including: gastric ulcer, duodenal ulcer, stomach or esophageal varices, ulcerative colitis, Crohn's disease, gastrointestinal cancer, familial genetic multiple intestinal polyps), and History of gastrointestinal perforation, gastrointestinal surgery that influence drug absorption, and other potential intestinal complications considered by researchers.
- ALT or Aspartate Aminotransferase (AST) > 2.5 × upper limit of normal (ULN), or serum creatinine > 1.5 × ULN.
- Neutropenia patient (neutrophil count < 1.5 × 10^9 / L).
- Active infection uncontrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CN128 TabletsAlso: CN128Iron chelator, oral tablets | Drug | CN128 Group |
Primary outcome
Number of participants with adverse events, adverse reactions, severe adverse events and severe adverse reactions as a measure of safety and tolerability during the study period.
Time frame: Up to 52 weeks
To determine the incidence, type and severity of adverse events, adverse reactions, severe adverse events and severe adverse reactions in patients up to 52 weeks.
Absolute Change in Weight (Unit: kg) From Baseline Over Time
Time frame: Baseline, 26, 39 and 52 weeks.
The patient's weight will be determined, and it's one kind of Physical examination.
Absolute Change in Height (Unit: m) From Baseline Over Time
Time frame: Baseline, 26, 39 and 52 weeks.
The patient's height will be determined, and it's one kind of Physical examination.
Absolute Change in Temperature (Unit: ℃）From Baseline Over Time
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
The patient's temperature will be determined, and it's one kind of vital signs checks.
Absolute Change in Blood pressure (Unit: mmHg ) From Baseline Over Time
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Both patient's systolic and diastolic blood pressure will be measured, and it's one kind of vital signs checks.
Absolute Change in Heart rate (Unit: bpm) From Baseline Over Time
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
The patient's heart rate will be determined, and it's one kind of vital signs checks.
Absolute Change in Respiration (Unit: bpm) From Baseline Over Time
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
The patient's respiration will be determined, and it's one kind of vital signs checks.
Absolute Change in Electrocardiogram (P-R (Unit: ms), QRS (Unit: ms), QTc interval (Unit: ms), etc) From Baseline Over Time
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
The patient's electrocardiogram will be measured, and it's one kind of laboratory test.
Change in Auditory Function From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's auditory function will be determined by otorhinolaryngology.
Absolute Change in White Blood Count (Unit: 10^9/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's white blood count will be determined, and it's one kind of laboratory test.
Absolute Change in Neutrophil Count (Unit: 10^9/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's neutrophil count will be determined, and it's one kind of laboratory test.
Absolute Change in Lymphocyte Count (Unit: 10^9/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's lymphocyte count will be determined, and it's one kind of laboratory test.
Absolute Change in Monocyte Count (Unit: 10^9/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's monocyte count will be determined, and it's one kind of laboratory test.
Absolute Change in Eosinophilic Count (Unit: 10^9/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's eosinophilic count will be determined, and it's one kind of laboratory test.
Absolute Change in Basophilic Count (Unit: 10^9/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's basophilic count will be determined, and it's one kind of laboratory test.
Absolute Change in Red Blood Count (Unit: 10^9/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's red blood count will be determined, and it's one kind of laboratory test.
Absolute Change in Hemoglobin (Unit: g/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's hemoglobin will be determined, and it's one kind of laboratory test.
Absolute Change in Hematocrit (Unit:%) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's hematocrit will be determined, and it's one kind of laboratory test.
Absolute Change in Blood Platelet Count (Unit: 10^9/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's blood platelet count will be determined, and it's one kind of laboratory test.
Absolute Change in Thrombocytocrit (Unit: %) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's thrombocytocrit will be determined, and it's one kind of laboratory test.
Absolute Change in Alanine Aminotransferase (Unit: U/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's alanine aminotransferase will be determined, and it's one kind of laboratory test.
Absolute Change in Total Bilirubin (Unit:µmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's total bilirubin will be determined, and it's one kind of laboratory test.
Absolute Change in Total Protein (Unit:g/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's total protein will be determined, and it's one kind of laboratory test.
Absolute Change in Albumin (Unit: g/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's albumin will be determined, and it's one kind of laboratory test.
Absolute Change in Globulin (Unit: g/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's globulin will be determined, and it's one kind of laboratory test.
Absolute Change in Alkaline Phosphatase (Unit: U/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's alkaline phosphatase will be determined, and it's one kind of laboratory test.
Absolute Change in Aspartate Aminotransferase (Unit: U/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's aspartate aminotransferase will be determined, and it's one kind of laboratory test.
Absolute Change in Lactate Dehydrogenase (Unit: IU/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's lactate dehydrogenase will be determined, and it's one kind of laboratory test.
Absolute Change in Urea (Unit: mmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's urea will be determined, and it's one kind of laboratory test.
Absolute Change in Creatinine (Unit:µmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's creatinine will be determined, and it's one kind of laboratory test.
Absolute Change in Glucose (Unit: mmol/L) From Baseline Over Time [ Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's glucose will be determined, and it's one kind of laboratory test.
Absolute Change in Potassium (Unit: mmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's potassium will be determined, and it's one kind of laboratory test.
Absolute Change in Sodium (Unit: mmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's sodium will be determined, and it's one kind of laboratory test.
Absolute Change in Chlorine (Unit: mmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's chlorine will be determined, and it's one kind of laboratory test.
Absolute Change in Calcium (Unit: mmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's calcium will be determined, and it's one kind of laboratory test.
Absolute Change in Fibrinogen (Unit: g/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's fibrinogen will be determined, and it's one kind of laboratory test.
Absolute Change in Prothrombin time (Unit: s) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's prothrombin time will be determined, and it's one kind of laboratory test.
Absolute Change in Activated Partial Thromboplastin Time (APTT, Unit: s) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's APTT will be determined, and it's one kind of laboratory test.
Absolute Change in Serum Total Thyroxine (Unit: nmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's serum total thyroxine will be determined, and it's one kind of laboratory test.
Absolute Change in Parathyroid Hormone (Unit: pg/mL) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's parathyroid hormone will be determined, and it's one kind of laboratory test.
Absolute Change in Total Triiodothyronine (Unit: nmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's total triiodothyronine will be determined, and it's one kind of laboratory test.
Absolute Change in Thyrotropin (Unit: mIU/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's thyrotropin will be determined, and it's one kind of laboratory test.
Absolute Change in Urine Glucose (Unit: mmol/L) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's urine glucose will be determined, and it's one kind of laboratory test.
Absolute Change in Urine Protein (Unit: g/L)) From Baseline Over Time
Time frame: Baseline, 2, 12, 26, 39 and 52 weeks.
The patient's urine protein will be determined, and it's one kind of laboratory test.
Absolute Change in Total Testosterone (Unit: ng/ml) in men From Baseline Over Time
Time frame: Baseline, 26, 39 and 52 weeks.
The patient's total testosterone will be determined in men, and it's one kind of laboratory test.
Absolute Change in Free Testosterone (Unit: nmol/L) in men From Baseline Over Time
Time frame: Baseline, 26, 39 and 52 weeks.
The patient's free testosterone will be determined in men, and it's one kind of laboratory test.
Absolute Change in Follicle-generating Hormone (Unit: mIU/mL) in women From Baseline Over Time
Time frame: Baseline, 26, 39 and 52 weeks.
The patient's follicle-generating hormone will be determined in women, and it's one kind of laboratory test.
Absolute Change in Luteinizing Hormon (Unit: mIU/mL) in women From Baseline Over Time
Time frame: Baseline, 26, 39 and 52 weeks.
The patient's luteinizing hormonwill be determined in women, and it's one kind of laboratory test.
2 secondary outcomes
Absolute Change in Liver iron content (Unit: mg/g dw) From Baseline Over Time
Time frame: Baseline, 12, 26,39 and 52 weeks.
Absolute Change in Serum ferritin (Unit: µg/L) From Baseline Over Time
Time frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 26, 39 and 52 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Luo, PhD principal investigator
First Affiliated Hospital of Guangxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CN128 Tablets in people with Thalassemia and Iron Overload, run by Hangzhou Zede Pharma-Tech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events, adverse reactions, severe adverse events and severe adverse reactions as a measure of safety and tolerability during the study period. (time frame: Up to 52 weeks). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.