Hypertension, PortalPhase 2/3NCT06470386
The Efficacy and Safety of Alverine in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis
A Phase 2/3 study testing Alverine and Carvedilol in people with Hypertension, Portal, run by Shanghai Changzheng Hospital.
Trial summary
Study Overall Design: This trial is a prospective, open-label, multicenter, randomized controlled clinical trial. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to either the Alverine treatment group or the Carvedilol treatment group in a 1:1 ratio after… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Portal
- What is being tested?
- Alverine and Carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Nov 2025
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years (inclusive), regardless of gender.
- Patients with cirrhosis confirmed by clinical, laboratory, imaging examinations, and/or liver biopsy.
- Hepatic venous pressure gradient (HVPG) ≥ 10 mmHg.
- Agree to participate and sign the informed consent form.
Who cannot join
- Use of non-selective beta-blockers such as Carvedilol, Propranolol, or Alverine, Papaverine, and their derivatives (e.g., Papaverine Hydrochloride, Drotaverine Hydrochloride) within 4 weeks prior to enrollment.
- Previous surgeries including transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation.
- History or current occurrence of overt hepatic encephalopathy, esophagogastric variceal bleeding, or grade 3 ascites.
- Use of vasoactive drugs such as somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine within 1 week prior to enrollment.
- History of heavy alcohol consumption within 12 weeks prior to enrollment and inability to abstain from heavy drinking during the study (equivalent to ethanol intake ≥30 g/day for males, ≥20 g/day for females).
- Serum total bilirubin level ≥3×ULN (≥5×ULN for autoimmune liver disease patients), or serum sodium level <125 mmol/L, or white blood cell count <1×10^9/L, or platelet count <30×10^9/L, or International Normalized Ratio (INR) >2.3.
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- Significant renal insufficiency (eGFR (CKD-EPI formula) <20 mL/min/1.73 m²).
- Presence of thrombosis or cavernous transformation in the portal venous system (including portal vein, splenic vein, superior mesenteric vein); patients with a history of portal vein thrombosis can be enrolled if no definite thrombosis is detected in the portal venous system within 2 weeks.
- HBV DNA or HCV RNA > the lower limit of detection; patients with active HCV antiviral treatment; patients on anti-HBV treatment for less than 24 weeks.
- Uncontrollable active infections (such as lung infection, abdominal infection, HIV, etc.) within 4 weeks prior to enrollment.
- Poorly controlled hypertension, diabetes, or other severe heart or lung diseases.
- Diagnosed or suspected malignancies, including liver cancer.
- Known allergy to Alverine, Papaverine and their derivatives (e.g., Papaverine Hydrochloride, Drotaverine Hydrochloride) or Carvedilol; contraindications for Carvedilol: NYHA class IV decompensated heart failure requiring intravenous inotropic drugs; asthma, chronic obstructive pulmonary disease (COPD) with bronchospasm; second or third degree atrioventricular block, severe bradycardia (heart rate less than 50 bpm), sick sinus syndrome (including sinoatrial block); cardiogenic shock; severe hypotension (systolic blood pressure less than 85 mmHg).
- Patients with glaucoma.
- Patients with psychiatric disorders.
- Pregnant or lactating women, or women with potential for pregnancy.
- Participation in other drug trials within 4 weeks prior to enrollment.
- Other reasons deemed unsuitable by the researchers.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy and Safety of Compound Alverine Citrate Soft Capsules in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis: a Prospective, Open-label, Multicentre, Randomised Controlled Trial
Study Overall Design:
This trial is a prospective, open-label, multicenter, randomized controlled clinical trial. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to either the Alverine treatment group or the Carvedilol treatment group in a 1:1 ratio after signing the informed consent form. After randomization, participants will enter a 24-week medication period. Apart from the baseline period, the efficacy of the treatment will be evaluated 24 weeks post-treatment. The safety evaluation will be conducted according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by the National Cancer Institute.
Read more
Study Population:
Patients with cirrhotic portal hypertension.
Interventions:
Alverine Group: Compound Alverine Citrate Capsules (Lejiansu; each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; manufactured by the French company UCB Pharma), 180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks.
Carvedilol Group: Jinluo (Carvedilol Tablets; 6.25 mg; manufactured by Qilu Pharmaceutical Co., Ltd.), taken orally, starting dose of 6.25 mg once a day, gradually adjusted according to heart rate to 6.25 mg twice a day, 12.5 mg in the morning and 6.25 mg in the evening, 12.5 mg twice a day, or adjusted to the maximum tolerated dose (heart rate greater than 55 beats/min and systolic blood pressure greater than 90 mmHg), taken continuously for 24 weeks.
Study Objectives:
- Primary Study Objective Evaluate the efficacy and safety of Compound Alverine Citrate Capsules in the treatment of cirrhotic portal hypertension.
- Secondary Study Objectives Evaluate the effect of Compound Alverine Citrate Capsules on the incidence of esophagogastric variceal bleeding and other cirrhotic decompensation events.
- Exploratory Study Objectives Evaluate the efficacy of Compound Alverine Citrate Capsules in the treatment of cirrhotic portal hypertension using other non-invasive detection methods. Observe the effects of Compound Alverine Citrate Capsules on the multi-omics characteristics of cirrhosis, reversal of portal hypertension, recompensation of decompensated cirrhosis, and prevention of the progression of cirrhosis to liver cancer.
Study Endpoints:
(1) Primary Study Endpoints
- The treatment response rate, defined as a reduction in HVPG of ≥10% from baseline or a reduction to below 12 mmHg after 24 weeks of treatment.
- The incidence, events, and severity of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment (evaluated according to CTCAE version 5.0). (2) Secondary Study Endpoints
- Incidence of esophagogastric variceal bleeding during treatment.
- Incidence of other cirrhotic decompensation events (new onset or progression of ascites, spontaneous bacterial peritonitis, overt hepatic encephalopathy, acute kidney injury/hepatorenal syndrome, primary liver cancer, etc.) during treatment.
- Reduction in HVPG from baseline after 24 weeks of treatment.
- Mortality/liver transplantation rate during treatment.
- Overall survival time of subjects.
- Reduction in mean arterial pressure (MAP) and heart rate from baseline after 24 weeks of treatment. (3) Exploratory Study Endpoints
- Changes in liver stiffness and spleen stiffness from baseline after 24 weeks of treatment.
- Improvement in liver function (Child-Pugh score, MELD score) after 24 weeks of treatment.
- Changes in cardiac function (left ventricular ejection fraction) from baseline after 24 weeks of treatment.
- Changes in imaging characteristics, blood/stool metabolomics characteristics, portal hypertension reversal biomarkers, cirrhosis recompensation biomarkers, and cirrhosis progression to liver cancer biomarkers after 24 weeks of treatment.
Sample Size Calculation:
In animal experiments, it was confirmed that there was no statistically significant difference in the effect of Alverine and Carvedilol in treating portal hypertension. Literature reports indicate that the treatment response rate of Carvedilol for cirrhotic portal hypertension is approximately 60%. Based on the sample size calculation method for non-inferiority trials with two samples, with a non-inferiority margin δ=0.20, a one-sided α=0.025, and β=0.2, the calculated sample size for each group is 74 cases, totaling 148 cases. Considering a 20% dropout rate, a total of 178 cases are needed.
- Conditions
- Hypertension, Portal
- Being tested
- Alverine, Carvedilol
- Keywords
- Cirrhotic portal hypertension, Alverine, Pharmacological therapy
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlverineDrug
Also called Compound Alverine Citrate Capsules
180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks
CarvedilolDrug
Also called Jinluo
taken orally, starting dose of 6.25 mg once a day, gradually adjusted according to heart rate to 6.25 mg twice a day, 12.5 mg in the morning and 6.25 mg in the evening, 12.5 mg twice a day, or adjusted to the maximum tolerated dose (heart rate greater than 55 beats/min and systolic blood pressure greater than 90 mmHg), taken continuously for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alverine Group | Experimental | Compound Alverine Citrate Capsules (Lejiansu; specification: each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; manufactured by the French company UCB Pharma), 180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks. Receives: Drug: Alverine |
| Carvedilol Group | Active comparator | Jinluo (Carvedilol Tablets; specification: 6.25 mg; manufactured by Qilu Pharmaceutical Co., Ltd.), taken orally, starting dose of 6.25 mg once a day, gradually adjusted according to heart rate to 6.25 mg twice a day, 12.5 mg in the morning and 6.25 mg in the evening, 12.5 mg twice a day, or adjusted to the maximum tolerated dose (heart rate greater than 55 beats/min and systolic blood pressure greater than 90 mmHg), taken continuously for 24 weeks. Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The response rate.
The response rate to treatment, defined as the percentage of patients with a decrease in HVPG of ≥10% from baseline or a decrease to below 12 mmHg after 24 weeks of treatment.
Measured: 24 weeks
Safety assessment.
The incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment The incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment.
Measured: 24 weeks
Secondary outcomes (7)
Incidence of esophageal and gastric variceal bleeding during treatment.
Measured: 24 weeks
Incidence of other cirrhosis decompensation events during treatment.
other cirrhosis decompensation events: new-onset ascites/progression of ascites, spontaneous bacterial peritonitis, overt hepatic encephalopathy, acute kidney injury/hepatorenal syndrome, primary liver cancer, etc.
Measured: 24 weeks
Degree of decrease in HVPG compared to baseline HVPG after 24 weeks of treatment.
Measured: 24 weeks
Mortality/liver transplantation rate during treatment.
Measured: 24 weeks
Overall survival time of the subjects.
Measured: 24 weeks
Degree of decrease in mean arterial pressure (MAP) compared to baseline values after treatment.
Measured: 24 weeks
Degree of decrease in heart rate compared to baseline values after treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PortalStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Shanghai East Hospital, Shanghai Zhongshan Hospital, Affiliated Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Nanchang University, Shanghai Public Health Clinical Center, Daping Hospital, Army Medical Center of PLA
- Responsible party
- Principal investigator, Wei-Fen Xie, Shanghai Changzheng Hospital
- Investigators
- Wei-Fen Xie, M.D., Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470386
- Sponsor's protocol ID
- CZXH-PH-ALV-2401
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 24 Jun 2024
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Compound Alverine Citrate Soft Capsules in the Treatment of Portal Hypertension in Patients With Liver Cirrhosis: a Prospective, Open-label, Multicentre, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06470386
- Acronym / sponsor ID
- CZXH-PH-ALV-2401
- Conditions
- Hypertension, Portal
- Keywords
- Cirrhotic portal hypertension, Alverine, Pharmacological therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Shanghai East Hospital, Shanghai Zhongshan Hospital, Affiliated Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Nanchang University, Shanghai Public Health Clinical Center, Daping Hospital, Army Medical Center of PLA
- Study start
- Jun 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 24 Jun 2024 (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.
Study Overall Design:
This trial is a prospective, open-label, multicenter, randomized controlled clinical trial. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to either the Alverine treatment group or the Carvedilol treatment group in a 1:1 ratio after signing the informed consent form. After randomization, participants will enter a 24-week medication period. Apart from the baseline period, the efficacy of the treatment will be evaluated 24 weeks post-treatment. The safety evaluation will be conducted according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by the National Cancer Institute.
Study Population:
Patients with cirrhotic portal hypertension.
Interventions:
Alverine Group: Compound Alverine Citrate Capsules (Lejiansu; each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; manufactured by the French company UCB Pharma), 180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks.
Carvedilol Group: Jinluo (Carvedilol Tablets; 6.25 mg; manufactured by Qilu Pharmaceutical Co., Ltd.), taken orally, starting dose of 6.25 mg once a day, gradually adjusted according to heart rate to 6.25 mg twice a day, 12.5 mg in the morning and 6.25 mg in the evening, 12.5 mg twice a day, or adjusted to the maximum tolerated dose (heart rate greater than 55 beats/min and systolic blood pressure greater than 90 mmHg), taken continuously for 24 weeks.
Study Objectives:
- Primary Study Objective Evaluate the efficacy and safety of Compound Alverine Citrate Capsules in the treatment of cirrhotic portal hypertension.
- Secondary Study Objectives Evaluate the effect of Compound Alverine Citrate Capsules on the incidence of esophagogastric variceal bleeding and other cirrhotic decompensation events.
- Exploratory Study Objectives Evaluate the efficacy of Compound Alverine Citrate Capsules in the treatment of cirrhotic portal hypertension using other non-invasive detection methods. Observe the effects of Compound Alverine Citrate Capsules on the multi-omics characteristics of cirrhosis, reversal of portal hypertension, recompensation of decompensated cirrhosis, and prevention of the progression of cirrhosis to liver cancer.
Study Endpoints:
(1) Primary Study Endpoints
- The treatment response rate, defined as a reduction in HVPG of ≥10% from baseline or a reduction to below 12 mmHg after 24 weeks of treatment.
- The incidence, events, and severity of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment (evaluated according to CTCAE version 5.0). (2) Secondary Study Endpoints
- Incidence of esophagogastric variceal bleeding during treatment.
- Incidence of other cirrhotic decompensation events (new onset or progression of ascites, spontaneous bacterial peritonitis, overt hepatic encephalopathy, acute kidney injury/hepatorenal syndrome, primary liver cancer, etc.) during treatment.
- Reduction in HVPG from baseline after 24 weeks of treatment.
- Mortality/liver transplantation rate during treatment.
- Overall survival time of subjects.
- Reduction in mean arterial pressure (MAP) and heart rate from baseline after 24 weeks of treatment. (3) Exploratory Study Endpoints
- Changes in liver stiffness and spleen stiffness from baseline after 24 weeks of treatment.
- Improvement in liver function (Child-Pugh score, MELD score) after 24 weeks of treatment.
- Changes in cardiac function (left ventricular ejection fraction) from baseline after 24 weeks of treatment.
- Changes in imaging characteristics, blood/stool metabolomics characteristics, portal hypertension reversal biomarkers, cirrhosis recompensation biomarkers, and cirrhosis progression to liver cancer biomarkers after 24 weeks of treatment.
Sample Size Calculation:
In animal experiments, it was confirmed that there was no statistically significant difference in the effect of Alverine and Carvedilol in treating portal hypertension. Literature reports indicate that the treatment response rate of Carvedilol for cirrhotic portal hypertension is approximately 60%. Based on the sample size calculation method for non-inferiority trials with two samples, with a non-inferiority margin δ=0.20, a one-sided α=0.025, and β=0.2, the calculated sample size for each group is 74 cases, totaling 148 cases. Considering a 20% dropout rate, a total of 178 cases are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alverine Group | Experimental | Drug: AlverineCompound Alverine Citrate Capsules (Lejiansu; specification: each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; manufactured by the French company UCB Pharma), 180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks. |
| Carvedilol Group | Active comparator | Drug: CarvedilolJinluo (Carvedilol Tablets; specification: 6.25 mg; manufactured by Qilu Pharmaceutical Co., Ltd.), taken orally, starting dose of 6.25 mg once a day, gradually adjusted according to heart rate to 6.25 mg twice a day, 12.5 mg in the morning and 6.25 mg in the evening, 12.5 mg twice a day, or adjusted to the maximum tolerated dose (heart rate greater than 55 beats/min and systolic blood pressure greater than 90 mmHg), taken continuously for 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 80 years (inclusive), regardless of gender.
- Patients with cirrhosis confirmed by clinical, laboratory, imaging examinations, and/or liver biopsy.
- Hepatic venous pressure gradient (HVPG) ≥ 10 mmHg.
- Agree to participate and sign the informed consent form.
Key exclusion criteria (18 listed)
- Use of non-selective beta-blockers such as Carvedilol, Propranolol, or Alverine, Papaverine, and their derivatives (e.g., Papaverine Hydrochloride, Drotaverine Hydrochloride) within 4 weeks prior to enrollment.
- Previous surgeries including transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation.
- History or current occurrence of overt hepatic encephalopathy, esophagogastric variceal bleeding, or grade 3 ascites.
- Use of vasoactive drugs such as somatostatin and its analogs, vasopressin, terlipressin, dopamine, norepinephrine within 1 week prior to enrollment.
- History of heavy alcohol consumption within 12 weeks prior to enrollment and inability to abstain from heavy drinking during the study (equivalent to ethanol intake ≥30 g/day for males, ≥20 g/day for females).
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 |
|---|---|---|
| AlverineAlso: Compound Alverine Citrate Capsules180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks | Drug | Alverine Group |
| CarvedilolAlso: Jinluotaken orally, starting dose of 6.25 mg once a day, gradually adjusted according to heart rate to 6.25 mg twice a day, 12.5 mg in the morning and 6.25 mg in the evening, 12.5 mg twice a day, or adjusted to the maximum tolerated dose (heart rate greater than 55 beats/min and systolic blood pressure greater than 90 mmHg), taken continuously for 24 weeks. | Drug | Carvedilol Group |
Primary outcome
The response rate.
Time frame: 24 weeks
The response rate to treatment, defined as the percentage of patients with a decrease in HVPG of ≥10% from baseline or a decrease to below 12 mmHg after 24 weeks of treatment.
Safety assessment.
Time frame: 24 weeks
The incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment The incidence of adverse events, serious adverse events, and adverse events leading to treatment discontinuation after treatment.
7 secondary outcomes
Incidence of esophageal and gastric variceal bleeding during treatment.
Time frame: 24 weeks
Incidence of other cirrhosis decompensation events during treatment.
Time frame: 24 weeks
Degree of decrease in HVPG compared to baseline HVPG after 24 weeks of treatment.
Time frame: 24 weeks
Mortality/liver transplantation rate during treatment.
Time frame: 24 weeks
Overall survival time of the subjects.
Time frame: 24 weeks
Degree of decrease in mean arterial pressure (MAP) compared to baseline values after treatment.
Time frame: 24 weeks
Degree of decrease in heart rate compared to baseline values after treatment.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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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.
Wei-Fen Xie, M.D. principal investigator
Shanghai Changzheng Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alverine and Carvedilol in people with Hypertension, Portal, run by Shanghai Changzheng Hospital.
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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang-Peng Zhu, M.D. (86-13671547663, zhuchangpeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate. (time frame: 24 weeks). The study lists 2 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 24 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.