Differentiated Thyroid CancerPhase 1/2NCT04137185
Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For rhTSH In Post-thyroidectomized Patients
A Phase 1/2 study testing Recombinant Human Thyroid Stimulating Hormone for Injection in people with Differentiated Thyroid Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- Recombinant Human Thyroid Stimulating Hormone for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2019to 29 Dec 2020
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer;
- Screening ages 18-75 (including 18 Age and 75 years old, male or female;
- Weight 45kg-80kg (including 45kg and 80kg, limited to the dose escalation test);
- Complete thyroidectomy or near total resection, and plan to start 131I diagnosis or ablation Patients
- Serum TSH ≤ 0.5 mU/L;
- Women of childbearing age are HCG-negative and must continue contraception until more than 3 months after the end of the trial;
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- Subjects (including partners) from 2 weeks prior to dosing to the last study drug There is no pregnancy plan within 3 months after the drug and voluntary effective contraceptive measures are taken. For specific contraceptive measures, see Appendix 3;
- Normal ECG. Intermittent atrial premature beats, supraventricular tachycardia (SVT) or supraventricular block-independent PR interval abnormalities, right bundle branch block, mild sinus bradycardia (asymptomatic, and no treatment required) Can be grouped;
- Low iodine diet before enrollment for more than 4 weeks;
- Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program.
Who cannot join
- Patients who are not eligible for THST withdrawal due to pituitary disease or other diseases;
- Patients not eligible for 131I diagnosis or treatment;
- Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function) Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection);
- Hypertensive patients who cannot be reduced to the following range due to medical treatment (systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg);
- Patients who have used any water-soluble radiographic contrast agent intravenously within 4 weeks before administration;
- Patients who underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months prior to administration;
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- taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy);
- before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia;
- pregnant or lactating women;
- a history of drug use and/or alcohol abuse within 3 months prior to dosing;
- patients who are allergic to rhTSH and its excipients;
- patients with positive infection-related tests : Includes hepatitis C and AIDS;
- Participated in any drug or medical device clinical trial within 1 month prior to the trial;
- Those who were unable to participate in the trial as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
Read the detailed description
This phase I/II study of rhTSH, To observe the safety and tolerability characteristics of different doses of rhTSH In Post-thyroidectomized Patients, and to observe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- Recombinant Human Thyroid Stimulating Hormone for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Thyroid Stimulating Hormone for InjectionDrug
Also called rhTSH
rhTSH was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH.
| Study group | Role | What they receive |
|---|---|---|
| rhTSH | Experimental | Phase 1: 0.9mgx1d、0.9mgx2d、1.8mgx1d、1.8mgx2d, intramuscularly (IM) ; Phase 2: patients will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the Phase 1. Receives: Drug: Recombinant Human Thyroid Stimulating Hormone for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
the maximum tolerated dose
Measured: up to 7 days
Secondary outcomes (5)
Cmax
maximum serum thyrotropin concentrations
Measured: up to 5 days
AUC
area under curve of serum thyrotropin concentration
Measured: up to 5 days
Serum Tg
serum Tg levels
Measured: up to 7 days
radioiodine uptake
whole body radioiodine imaging after rhTSH administration and after thyroid hormone withdrawal
Measured: up to 8 weeks
adverse event
classification and degree of adverse events
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start10 Jun 2019
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yansong Lin, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137185
- Sponsor's protocol ID
- ZGTSH001
- Status last verified
- Mar 2024
- First submitted
- 20 Sep 2019
- Last updated
- 6 Mar 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
- ClinicalTrials.gov ID
- NCT04137185
- Acronym / sponsor ID
- ZGTSH001
- Conditions
- Differentiated Thyroid Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 23 Oct 2019 (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.
Phase I/II Clinical Trial of Dose-tolerance, Pharmacokinetics and Iodine Uptake Effects For Recombinant Human Thyroid Stimulating Hormone In Post-thyroidectomized Patients
Detailed description
This phase I/II study of rhTSH, To observe the safety and tolerability characteristics of different doses of rhTSH In Post-thyroidectomized Patients, and to observe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhTSH | Experimental | Drug: Recombinant Human Thyroid Stimulating Hormone for InjectionPhase 1: 0.9mgx1d、0.9mgx2d、1.8mgx1d、1.8mgx2d, intramuscularly (IM) ; Phase 2: patients will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the Phase 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer;
- Screening ages 18-75 (including 18 Age and 75 years old, male or female;
- Weight 45kg-80kg (including 45kg and 80kg, limited to the dose escalation test);
- Complete thyroidectomy or near total resection, and plan to start 131I diagnosis or ablation Patients
- Serum TSH ≤ 0.5 mU/L;
Key exclusion criteria (14 listed)
- Patients who are not eligible for THST withdrawal due to pituitary disease or other diseases;
- Patients not eligible for 131I diagnosis or treatment;
- Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function) Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection);
- Hypertensive patients who cannot be reduced to the following range due to medical treatment (systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg);
- Patients who have used any water-soluble radiographic contrast agent intravenously within 4 weeks before administration;
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 |
|---|---|---|
| Recombinant Human Thyroid Stimulating Hormone for InjectionAlso: rhTSHrhTSH was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH. | Drug | rhTSH |
Primary outcome
MTD
Time frame: up to 7 days
the maximum tolerated dose
5 secondary outcomes
Cmax
Time frame: up to 5 days
AUC
Time frame: up to 5 days
Serum Tg
Time frame: up to 7 days
radioiodine uptake
Time frame: up to 8 weeks
adverse event
Time frame: up to 8 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 6 Mar 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.
Yansong Lin, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Human Thyroid Stimulating Hormone for Injection in people with Differentiated Thyroid Cancer, run by Suzhou Zelgen Biopharmaceuticals 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 10 inclusion and 14 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 6 Mar 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
MTD (time frame: up to 7 days). 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 6 Mar 2024.