A Phase 2 interventional study of All-trans retinoic acid and Danazol in Autoimmune Thrombocytopenia, sponsored by Peking University People's Hospital. Completed at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
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.
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.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's enrollment of 130 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Exclusion Criteria:
Danazol 400mg po and ATRA 10mg bid po
Drug: All-trans retinoic acid · Drug: Danazol
Danazol 400mg po
Drug: Danazol
Also known as: Retinoid acid
Also known as: Danocrine, Cleregil, Danol
the sustained platelet response at the 12-month follow-up
The number of participants (responders) with platelet count \>=30x10\^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count \>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 12-month follow-up.
Time frame: From the start of study treatment (Day 1) up to the end of Month 12
overall response
The number of participants with platelet count \>=30×10\^9/L at least once and at least a doubling of the baseline platelet count without the administration of any other platelet increasing therapy
Time frame: From the start of study treatment (Day 1) up to the end of Month 12
primary response rate at 4 weeks
The number of participants with platelet count \>=30×10\^9/L and at least a doubling of the baseline platelet count without the administration of any other platelet increasing therapy at week 4 of treatment
Time frame: From the start of study treatment (Day 1) up to week 4 of treatment
primary response rate at 8 weeks
The number of participants with platelet count \>=30×10\^9/L and at least a doubling of the baseline platelet count without the administration of any other platelet increasing therapy at week 8 of treatment
Time frame: From the start of study treatment (Day 1) up to week 8 of treatment
time to response
Time to response was defined as the time from starting treatment to the time to achieve the response.
Time frame: From the start of study treatment (Day 1) up to the end of month 12
duration of response
Duration of response was measured from the achievement of response to the loss of response.
Time frame: From the start of study treatment (Day 1) up to the end of month 12
reduction in bleeding symptoms
Changes of bleeding after treatment. Bleeding was defined in accordance with the WHO bleeding scale (0, no bleeding; 1, petechiae; 2, mild blood loss; 3, gross blood loss; and 4, debilitating blood loss).
Time frame: From the start of study treatment (Day 1) up to the end of month 12
safety
All patients were assessed for safety every week during the first 8 weeks of treatment, and at 2-week intervals thereafter. Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: From the start of study treatment (Day 1) up to the end of follow-up
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital