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Efficacy and Safety Study of rhTSH for Adjuvant Radioiodine Ablation Therapy in Patients With Differentiated Thyroid Cancer

NCT04964284 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2023-10-23

No results posted yet for this study

Summary

This study was conducted in patients with differentiated thyroid cancer who had undergone total/near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid remnant ablation. One group of patients who took thyroid hormone medicine and were euthyroid \[i.e. their thyroid stimulating hormone (TSH) levels are normal\], and received injections of rhTSH (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high), and were given oral radioiodine.

Conditions

  • Differentiated Thyroid Cancer

Interventions

BIOLOGICAL

rhTSH

rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH

RADIATION

Radioiodine (131I)

Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-06
Primary Completion
2024-09-30
Completion
2024-12-31

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 NCT04964284 on ClinicalTrials.gov