Combination of Danazole With Berberine in the Treatment of ITP

NCT ID: NCT03909763

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-20
• Study Completion Date: 2021-06-30

Brief Summary

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

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.

Conditions

Corticosteroid-resistant or Relapsed ITP

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Berberine plus danazol

Berberine plus danazol group

Group Type: EXPERIMENTAL

Berberine plus danazol

Intervention Type: DRUG

Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks

Interventions

Berberine plus danazol

Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks

Intervention Type: DRUG

Other Intervention Names

HangZhou Mingsheng of China

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaohui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University of people's hospital

Locations

Peking University Institute of Hematology

Beijing, Beijing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ZXH81470343

Identifier Type: -

Identifier Source: org_study_id