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RecruitingNCT06176911Updated Dec 20, 2023

The Combination of Teriflunomide and Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

A Phase 2 interventional study of Teriflunomide and Danazol in Immune Thrombocytopenia, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To compare the efficacy and safety of teriflunomide plus danazol versus danazol in patients with steroid-resistant/relapse ITP

Read the detailed description

This is a prospective, multicenter, randomized, controlled trial of 124 adult patients with steroid-resistant/relapse ITP in China. Patients were randomized to receive either experimental teriflunomide plus danazol or active comparator danazol monotherapy. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patient's request.

02

Conditions studied

  • Immune Thrombocytopenia

Keywords

  • Teriflunomide
  • Danazol
03

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 124 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
  2. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid tapering or after its discontinuation;
  3. Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
  4. Willing and able to sign written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection, or patients with confirmed autoimmune disease);
  2. Active or a history of malignancy;
  3. Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN);
  4. Pregnancy or lactation;
  5. Current or recent (\< 4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
  6. Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
  7. Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB;
  8. Have experienced a clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled;
  9. Patients who are deemed unsuitable for the study by the investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    Teriflunomide plus danazol

    Oral teriflunomide was given at a starting dose of 7 mg once daily and danazol was given at a dose of 200mg twice daily for 24 weeks. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patient's request.

    Drug: Teriflunomide · Drug: Danazol

  • Active comparator
    Danazol

    Danazol was given at a dose of 200 mg twice a day for 24 weeks. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patient's request.

    Drug: Danazol

Interventions

  • DrugTeriflunomide

    Starting dose of 7 mg once daily. Dose adjustments are made throughout the study based on individual platelet counts.

    Also known as: AUBAGIO

  • DrugDanazol

    200 mg twice daily.

06

What researchers measure

Primary outcomes

  1. Sustained response

    Platelet count over 30,000/μL and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy for at least four of the six visits between weeks 19 and 24.

    Time frame: From the start of study treatment (Day 1) to the end of week 24

Secondary outcomes

  1. Overall response

    Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding. Response (R) was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count and absence of bleeding.

    Time frame: From the start of study treatment (Day 1) to the end of week 24

  2. Time to response

    The time from treatment initiation to achieve a CR or a R.

    Time frame: From the start of study treatment (Day 1) to the end of week 24

  3. Duration of response

    The time from the achievement of a complete response or a partial response to the loss of response.

    Time frame: From the start of study treatment (Day 1) to the end of week 24

  4. Initial response

    The number of participants with achievement of CR or R at 4 weeks.

    Time frame: From the start of study treatment (Day 1) up to week 4 of treatment

  5. Bleeding events

    Clinically significant bleeding was assessed using the World Health Organization (WHO) bleeding scale.

    Time frame: From the start of study treatment (Day 1) to the end of week 24

  6. Adverse events

    Adverse events (AEs) were reported and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

    Time frame: From the start of study treatment (Day 1) to the end of week 24

  7. Health-related quality of life (HRQoL)

    ITP-PAQ was used to assess the Health-Related Quality of Life (HRQoL) before and after treatment.

    Time frame: From the start of study treatment (Day 1) to the end of week 24

07

Study locations

1 of 1 sites recruiting
  • Peking University Insititute of Hematology, Peking University People's Hospital
    Beijing, Beijing 100010, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06176911
Lead sponsor
Peking University People's Hospital
Collaborators
Beijing Luhe Hospital, Chinese PLA General Hospital, Navy General Hospital, Beijing, Beijing Hospital, Beijing Friendship Hospital, Peking University First Hospital, Peking University Third Hospital, China-Japan Friendship Hospital, Beijing Tsinghua Changgeng Hospital
Responsible party
Xiao Hui Zhang (Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital) — Principal investigator
First posted
Dec 20, 2023
Start date
Dec 5, 2023
Primary completion
Dec 30, 2024 (estimated)
Completion
Jul 15, 2025 (estimated)
Last update
Dec 20, 2023

Study contacts

Xiao-Hui Zhang, MD
Contact
zhangxh100@sina.com
+8613522338836
Li-Ping Yang, MD
Contact
lpyangvip@163.com
+8618519172033
Xiao-Hui Zhang, MD
principal investigator · Peking University Institute of Hematology, Peking University People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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