Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura
Information source: Beth Israel Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thrombotic Thrombocytopenic Purpura
Intervention: Danazol (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Beth Israel Medical Center Official(s) and/or principal investigator(s): Mala Varma, M.D., Principal Investigator, Affiliation: Mount Sinai St. Luke's
Overall contact: Mala Varma, M.D., Phone: 212-523-7281, Email: mvarma@chpnet.org
Summary
The purpose of the study is to find out if administration of Danazol with plasma exchange
and corticosteroids will reduce the number of plasma exchanges required to control
Thrombotic Thrombocytopenic Purpura.
Clinical Details
Official title: Phase II Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To assess the total number of plasma exchanges performed within 30 days of initiation of the first plasma exchange.
Secondary outcome: Time to Remission
Detailed description:
Danazol is a synthetic steroid hormone structurally resembling a group of natural hormones
(androgens)found in the body. Danazol has immune modifying activity and is effective in
treatment of blood disorders with low platelet counts such as idiopathic thrombocytopenic
purpura (however FDA has not yet approved danazol for this disorder). A study of Danazol on
conjunction with plasma exchange for thrombotic thrombocytopenic purpura showed that Danazol
decreased the number of plasma exchanges required by approximately 80% and reduced the time
needed to control the disease. It's not clear how Danazol works in TTP. It is not approved
by the FDA for the treatment of TTP.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- TTP with platelets less than 10,000 and microangiopathic hemolytic anemia
- Age greater than 18 and less than 60
- LDH > 2x upper limit of normal
- PT and PTT normal
- Patients must give signed informed consent
- Pre-menopausal woman must have negative pregnancy test.
- TTP not related to underlying cancer, treatment of cancer or transplantation.
- TTP not associated with drugs.
Exclusion Criteria:
- LFTs AST/ALT > 2x upper limit of normal
- Hepatitis B and Hepatitis C infection.
- HIV with active opportunistic infections
- Acute or chronic Disseminated Intravascular Coagulation (DIC), defined as D-dimer
8ug/ml and fibrinogen<100 mg/dl
- TTP related to drugs, malignancy and transplantation.
- Pregnancy
- Concurrent other investigational drug use during this study.
- Porphyria.
Locations and Contacts
Mala Varma, M.D., Phone: 212-523-7281, Email: mvarma@chpnet.org
Mount Sinai St. Luke's, New York, New York 10019, United States; Recruiting Mala Varma, M.D., Phone: 212-523-7281, Email: mvarma@chpnet.org Tahir Mirzoyev, Phone: 212-523-7289, Email: tmmirzoye@chpnet.org Mala Varma, M.D., Principal Investigator
Additional Information
Starting date: October 2008
Last updated: July 17, 2015
|