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A randomized, open-lable, multicenter, controlled phase III clinical trial to evaluate the safety and efficacy of recombinant human thryoid stimulating hormone (SNA001) in postoperative RAI treatment of differentiated thyroid cancer patients

A randomized, open-lable, multicenter, controlled phase III clinical trial to evaluate the safety and efficacy of recombinant human thryoid stimulating hormone (SNA001) in postoperative RAI treatment of differentiated thyroid cancer patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046907
Enrollment
Unknown
Registered
2021-05-30
Start date
2020-03-10
Completion date
Unknown
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

differentiated thyroid cancer

Interventions

experiment group:SNA001 injection
controll group:THW

Sponsors

Zhongshan Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, male and female, when signing informed consent form; 2. Willingness to participate clinical study, and sign ICF, who possessed behavioral abilitity; 3. ECOG score 0-1 at screening phase(see Appendix 1); 4. Basal heart rate 55-110 time/min at screening phase(boundary value included); 5. Blood pressure =4 weeks) before screening; 8. TSH treatment >=4 weeks after total or near total thyroidectomy; 9. Low iodine diet for two weeks before screening phase; 10. According to AJCC Seventh Version, T1-3, N0-1, or NxM0(see Appendix 2); 11. TSH< 5mU/L detected in study sites at screening phase;

Exclusion criteria

Exclusion criteria: 1. Estimated survival time 10 ng/mL without disturbance of TgAb; 8. Patients combined with thyroiditis.

Design outcomes

Primary

MeasureTime frame
remnant ablative rate;

Secondary

MeasureTime frame
Serum Tg and TgAb level;Serum TSH level;131I dosage;

Countries

China

Contacts

Public ContactLiu Bin

West China Hospital, Sichuan University

binl@foxmail.com+86 18980606827

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026