Cholangitis, SclerosingPhase 2NCT00004762
Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis
A Phase 2 study testing cladribine in people with Cholangitis, Sclerosing, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: I. Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangitis, Sclerosing
- What is being tested?
- cladribine
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Dec 1994to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Stage I-III primary sclerosing cholangitis
Radiologically and pathologically documented
No concomitant liver disease, e.g.:
- Viral hepatitis
- Autoimmune hepatitis
- Primary biliary cirrhosis
- Cirrhosis
- Portal hypertension or associated complications
- Jaundice caused by dominant stricture
--Prior/Concurrent Therapy--
No concurrent immunosuppressives
--Patient Characteristics--
Hematopoietic:
- Absolute neutrophil count at least 2500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 10 g/dL
Other:
- 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
Endoscopic retrograde cholangiopancreatography within 36 months prior to registration
Liver biopsy within 12 months prior to registration
About this study
OBJECTIVES:
- Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis.
Read the detailed description
PROTOCOL OUTLINE:
Patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-CdA) for 5 consecutive days every month for 3 months.
- Conditions
- Cholangitis, Sclerosing
- Being tested
- cladribine
- Keywords
- gastrointestinal disorders, primary sclerosing cholangitis, rare disease
- Medical subject headings
- Cholangitis, Sclerosing, Gastrointestinal Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cladribineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startDec 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangitis, SclerosingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 5 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Scripps Clinic
- Investigators
- Paul J. Pockros, Study chair, Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004762
- Sponsor's protocol ID
- 199/11707
- Other IDs
- SCRF-94304
- Status last verified
- Dec 2001
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis
- ClinicalTrials.gov ID
- NCT00004762
- Acronym / sponsor ID
- 199/11707
- Conditions
- Cholangitis, Sclerosing
- Keywords
- gastrointestinal disorders, primary sclerosing cholangitis, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Scripps Clinic
- Study start
- Dec 1994
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Evaluate the effects of cladribine (2-chlorodeoxyadenosine; 2-CdA) on biochemical, radiologic, and histologic parameters in patients with early stage primary sclerosing cholangitis.
Detailed description
PROTOCOL OUTLINE:
Patients are treated with subcutaneous injections of cladribine (2-chlorodeoxyadenosine; 2-CdA) for 5 consecutive days every month for 3 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cladribine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J. Pockros study chair
Scripps Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cladribine in people with Cholangitis, Sclerosing, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.