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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

Page last updated: August 23, 2015

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