Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2015-11-19

Brief Summary

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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 (TTP).

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Detailed Description

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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 in 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.

Conditions

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Thrombotic Thrombocytopenic Purpura

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Danazol, Plex, Steroids

Everyone will receive Danazol with plasma exchange and corticosteroids

Group Type EXPERIMENTAL

Danazol

Intervention Type DRUG

Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.

Historic Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Danazol

Danazol 600 mg PO will be initiated with plasma exchange and corticosteroids at the time of enrollment.

Intervention Type DRUG

Other Intervention Names

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Plasma Exchange Corticosteroids

Eligibility Criteria

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Inclusion Criteria

* TTP with platelets less than 100,000 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No