Combination of Danazole With Berberine in the Treatment of ITP

NCT03909763 | Unknown Phase 2 Results DMC

• 1 other identifier: ZXH81470343
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Corticosteroid-resistant or Relapsed ITP

Keywords

corticosteroid-resistant or relapsed ITP; Danazole; berberine

Outcome Measures

Primary Outcomes (1)

• The Count of Participants That Achieved 6-month Sustained Response

  6-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))

  6 month

Secondary Outcomes (3)

• the Count of Participants That Had Adverse Events

  2 years

• the Count of Participants That Achieved Initial Response

  4 weeks

• DOR

  2 years

Study Arms (1)

Berberine plus danazol

EXPERIMENTAL

Berberine plus danazol group

Drug: Berberine plus danazol

Interventions

Berberine plus danazol DRUG

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

Also known as: HangZhou Mingsheng of China

Berberine plus danazol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dL
• 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
• Have a New York Heart Classification III or IV heart disease
• Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
• Have active hepatitis B or hepatitis C infection
• Have a HIV infection
• Have active infection requiring antibiotic therapy within 7 days prior to study entry
• Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
• Previous treatment with rituximab
• Previous splenectomy
• Had previous or concomitant malignant disease
• Not willing to participate in the study.
• Expected survival of \< 2 years
• Intolerant to murine antibodies
• Immunosuppressive treatment within the last month

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Berberine; Danazol

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Xiaohui Zhang, Director of Clinical Trials
• Organization: Peking University People's Hospital

zhangxh@bjmu.edu.cn

86-10-88324577

Study Officials

• Xiaohui Zhang, MD

  Peking University of people's hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: January 20, 2016
• Primary Completion: December 30, 2020
• Study Completion: June 30, 2021
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)