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Combination of Danazole With Berberine in the Treatment of ITP

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ClinicalTrials.gov Identifier: NCT03909763
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Brief Summary:
A prospective, multicenter, open-label, Phase II, single arm, trial performed in 6 departments of hematology in China

Condition or disease Intervention/treatment Phase
Corticosteroid-resistant or Relapsed ITP Drug: Berberine plus danazol Phase 2

Detailed Description:
Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count and mucocutaneous bleeding. Approximately one-third of ITP patients fail to respond to first-line therapies. In addition, a certain amount of the patients relapse and require further therapy after one or more treatment strategies (e.g., thrombopoietin receptor agonists or rituximab). The optimal second-line treatment remains a challenge.Berberine (BBR), an isoquinoline alkaloid derived from plants, is widely used as a nonprescription drug to treat diarrhea. Our previous data demonstrated that gut microbiota dysbiosis may contribute to the development of corticosteroid-resistant ITP. BBR may correct corticosteroid-resistance by modulating the gut microbiota structure, thus being a novel potential second-line candidate to treat ITP. Importantly, the potential clinical benefits of BBR have already been evaluated in various studies using human subjects, and it has been shown to be safe. Danazol is an attenuated androgen that has successfully been used in the treatment of ITP. Considering the side-effects of a regular dose of danazol and that BBR and danazol share disparate mechanisms in the treatment of ITP, we hypothesized that the combination of these two agents might be a promising option to maximize efficacy while minimizing adverse effects. Therefore, we aimed to evaluate the long-term efficacy and safety of berberine plus danazol in patients with corticosteroid-resistant or relapsed ITP.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Danazole With Berberine in the Treatment of ITP
Actual Study Start Date : January 20, 2016
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Danazol

Arm Intervention/treatment
Experimental: Berberine plus danazol
Berberine plus danazol group
Drug: Berberine plus danazol
Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
Other Name: HangZhou Mingsheng of China




Primary Outcome Measures :
  1. 12-month sustained response [ Time Frame: 1 year ]
    12-month sustained response defined as platelet count of 30×10⁹/L or more and at least a doubling of baseline platelet count (partial response (PR)), or a platelet count of 100×10⁹/L or more and the absence of bleeding without rescue medication(complete response (CR))


Secondary Outcome Measures :
  1. adverse event/serious adverse event and cumulative rate of bleeding [ Time Frame: 1 year ]
    adverse event/serious adverse event associated with study drugs and cumulative rate of bleeding

  2. initial response [ Time Frame: 1 year ]
    initial response by day 28

  3. DOR [ Time Frame: 1 year ]
    duration of response (DOR)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
  2. Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation
  3. Subject is ≥ 18 years and ≤80years
  4. Subject has signed and dated written informed consent.
  5. Fertile patients must use effective contraception during treatment and observational period
  6. Negative pregnancy test

Exclusion Criteria:

  1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
  2. Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit of normal
  3. Have a New York Heart Classification III or IV heart disease
  4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
  5. Have active hepatitis B or hepatitis C infection
  6. Have a HIV infection
  7. Have active infection requiring antibiotic therapy within 7 days prior to study entry
  8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
  9. Previous treatment with rituximab
  10. Previous splenectomy
  11. Had previous or concomitant malignant disease
  12. Not willing to participate in the study.
  13. Expected survival of < 2 years
  14. Intolerant to murine antibodies
  15. Immunosuppressive treatment within the last month
  16. Connective tissue disease
  17. Autoimmune hemolytic anemia
  18. Patients currently involved in another clinical trial with evaluation of drug treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909763


Contacts
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Contact: Xiaohui Zhang, MD 010-88324981 zhangxh100@sina.com
Contact: yun He, MD 18910504949 polaris099@126.com

Locations
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China, Beijing
Peking University Institute of Hematology Recruiting
Beijing, Beijing, China, 100044
Contact: Xiao-Hui Zhang, MD    +86 13522338836    zhangxh100@sina.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiaohui Zhang, MD Peking University of people's hospital

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Responsible Party: Xiao Hui Zhang, Prof., Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03909763    
Other Study ID Numbers: ZXH81470343
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao Hui Zhang, Peking University People's Hospital:
corticosteroid-resistant or relapsed ITP
Danazole
berberine
Additional relevant MeSH terms:
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Danazol
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs