Trial Outcomes & Findings for Combination of Danazole With Berberine in the Treatment of ITP (NCT NCT03909763)

NCT ID: NCT03909763

Last Updated: 2020-09-25

Results Overview

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))

• Recruitment status: UNKNOWN
• Study phase: PHASE2
• Target enrollment: 55 participants
• Primary outcome timeframe: 6 month
• Results posted on: 2020-09-25

Participant Flow

Participant milestones

Measure	Berberine Plus Danazol Berberine plus danazol group Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
Overall Study STARTED	55
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Berberine Plus Danazol n=45 Participants Berberine plus danazol group Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
Age, Continuous	45 years n=45 Participants
Sex: Female, Male Female	29 Participants n=45 Participants
Sex: Female, Male Male	16 Participants n=45 Participants

PRIMARY outcome

Timeframe: 6 month

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))

Outcome measures

Measure	Berberine Plus Danazol n=45 Participants Berberine plus danazol group Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
The Count of Participants That Achieved 6-month Sustained Response	28 Participants

SECONDARY outcome

Timeframe: 2 years

any adverse events/serious adverse events associated with study drugs and bleeding events

Outcome measures

Measure	Berberine Plus Danazol n=45 Participants Berberine plus danazol group Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
the Count of Participants That Had Adverse Events Adverse events associated with study drugs	4 Participants
the Count of Participants That Had Adverse Events Bleeding events	1 Participants
the Count of Participants That Had Adverse Events No adverse events	40 Participants

SECONDARY outcome

Timeframe: 4 weeks

Initial response by day 28. Initial response includes partial response (PLT of 30×10⁹/L or more and at least a doubling of baseline platelet count) and complete response (PLT of 100×10⁹/L or more and the absence of bleeding without rescue medication).

Outcome measures

Measure	Berberine Plus Danazol n=45 Participants Berberine plus danazol group Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
the Count of Participants That Achieved Initial Response	21 Participants

SECONDARY outcome

Timeframe: 2 years

duration of response (DOR)

Outcome measures

Measure	Berberine Plus Danazol n=45 Participants Berberine plus danazol group Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
DOR	9.2 months Standard Deviation 10.731

Adverse Events

Berberine Plus Danazol

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Berberine Plus Danazol n=45 participants at risk Berberine plus danazol group Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
Blood and lymphatic system disorders Intracranial bleeding	2.2% 1/45 • 2 years

Other adverse events

Measure	Berberine Plus Danazol n=45 participants at risk Berberine plus danazol group Berberine plus danazol: Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
Endocrine disorders seborrheic dermatitis	6.7% 3/45 • Number of events 3 • 2 years
Endocrine disorders androgenetic alopecia	2.2% 1/45 • Number of events 1 • 2 years

Additional Information

Dr. Xiaohui Zhang, Director of Clinical Trials

Peking University People's Hospital

Phone: 86-10-88324577

Email: zhangxh@bjmu.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place