Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis

Sponsor

National Center for Research Resources (NCRR) (NIH)

Overall Status

Completed

CT.gov ID

NCT00004762

Collaborator

Scripps Clinic (Other)

Enrollment

Study Details

Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis.

Condition or Disease	Intervention/Treatment	Phase
Cholangitis, Sclerosing	Drug: cladribine	Phase 2

Patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-CdA) for 5 consecutive days every month for 3 months.

Study Type:

Interventional

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 1994

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

--Disease Characteristics--

Stage I-III primary sclerosing cholangitis

Radiologically and pathologically documented

--Prior/Concurrent Therapy--

No concurrent immunosuppressives

--Patient Characteristics--

No active infection
No fistula abscess
No active inflammatory bowel disease
Quiescent disease allowed, including: Chronic ulcerative colitis Crohn's disease
No other significant immunologic disorder
No active malignancy
No active alcohol or drug abuse
No pregnant or nursing women
Effective contraception required of fertile patients