NCT03909763

Combination of Danazole With Berberine in the Treatment of ITP

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Berberine plus danazol	Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks

Timeline

• Start date: 2016-01-20
• Primary completion: 2020-12-30
• Completion: 2021-06-30
• First posted: 2019-04-10
• Last updated: 2020-09-25
• Results posted: 2020-09-25

Locations

1 site across 1 country: China