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The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.

NCT04447183 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-23

No results posted yet for this study

Summary

This is a randomized, open, parallel controlled, multi-center clinical trial; 120 subjects were randomly assigned to the test group and the control group according to 3:1.

Conditions

  • Differentiated Thyroid Cancer

Interventions

DRUG

Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)

rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral

OTHER

radioactive iodine

radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral

Sponsors & Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Yansong Lin, PhD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-23
Primary Completion
2024-08-31
Completion
2024-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447183 on ClinicalTrials.gov