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Withdraw by the investigator Efficacy and safety of danazol combined with low-dose glucocorticoids in the treatment of refractory/recurrent primary immune thrombocytopenia: a multicenter, single arm, prospective and open clinical study

Efficacy and safety of danazol combined with low-dose glucocorticoids in the treatment of refractory/recurrent primary immune thrombocytopenia: a multicenter, single arm, prospective and open clinical study prospective and open clinical study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016177
Enrollment
Unknown
Registered
2018-05-17
Start date
2018-07-01
Completion date
Unknown
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune thrombocytopenic purpura

Interventions

experimental group:danazol combined with low-dose glucocorticoids

Sponsors

Second Affiliated Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. voluntarily signing the informed consent form and being able to comply with the research scheme; 2. meet the diagnostic criteria of refractory primary ITP; (1) platelet count was less than 30 x 10^9 / l for two consecutive times ( not within the same day ); (2) ineffective or recurrent splenectomy and hormone dependence or ineffective recurrence; (3) treatment is needed to reduce the risk of bleeding; (4) except other secondary thrombocytopenia. 3. there is no definite upper limit for postmenopausal women; 4. There is no obvious dysfunction such as heart, lung, liver and kidney, and uncontrollable hypertension and diabetes.

Exclusion criteria

Exclusion criteria: 1. secondary thrombocytopenia; 2. complicated with serious heart-lung and liver-kidney diseases; 3. specific allergic constitution and intolerance to therapeutic drugs; 4. previous history of thrombosis; 5. merger of neoplastic diseases; 6. patients with severe osteoporosis; 7. patients with mental history; 8. suspected or did have a history of alcohol and drug abuse; 9. serious or uncontrollable infection; 10. participants in other clinical trials in recent 4 weeks; 11. cannot be followed up regularly.

Design outcomes

Primary

MeasureTime frame
the number of platelets;

Countries

China

Contacts

Public ContactYan Jinsong

Second Affiliated Hospital of Dalian Medical University

yanjsdmu@126.com+86 17709871028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026