NCT01667263

The Combination of ATRA and Danazol as Second-line Treatment in Adult Immune Thrombocytopenia

The Combination of Oral All-trans Retinoic Acid and Danazol vs Danazol as Second-line Treatment in Adult Immune Thrombocytopenia: a Multicenter, Randomized, Open-label Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, open-label, multicentre study to compare the efficacy and safety of ATRA plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.

Detailed description

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of corticosteroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. All-trans retinoic acid (ATRA) has an immunomodulatory effect on haematopoiesis, making it a possible treatment option. A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to ATRA+danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study, in order to compare the efficacy and safety of ATRA plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.

Conditions

• Autoimmune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	All-trans retinoic acid
DRUG	Danazol

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-07-01
• Completion: 2017-02-01
• First posted: 2012-08-17
• Last updated: 2017-09-07

Locations

5 sites across 1 country: China