Open Label Extension Study to Protocol C2/13/DR-6MP-02
Information source: Teva GTC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: 80 mg DR-6MP (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Teva GTC Official(s) and/or principal investigator(s): Yaron Ilan, MD, Principal Investigator, Affiliation: Hadassah Medical Center Eran Goldin, MD, Principal Investigator, Affiliation: Shaare Zedek Medical Center
Summary
The open label extension study (Protocol C2/13/DR-6MP-02 EXT) is designed to evaluate the
clinical efficacy and safety of 80 mg DR-6MP test formulation for an additional 12 weeks in
subjects who already completed 12 weeks of Protocol C2/13/DR-6MP-02. Crohn's disease (CD)
therapy is aimed at reducing inflammation via induction of remission after a flare-up and
maintenance of the remission for as long as possible. The questions being asked in this
extension study are:
1. For subjects who received 80 mg DR-6MP for 12 weeks: Can the clinical efficacy and
safety status achieved following 12 weeks of treatment be maintained or improved
following an additional 12 weeks of DR-6MP treatment?
2. For subjects who received oral Purinethol (1-1. 5 mg/kg daily) for 12 weeks: Can the
clinical efficacy and safety at 12 weeks be maintained or improved following the
introduction of 12 weeks of 80 mg DR-6MP treatment?
Clinical Details
Official title: Clinical Efficacy and Safety of Delayed Release 6-Mercaptopurine (DR-6MP) for Targeted Ileal Delivery in Patients With Moderately Active Crohn's Disease - Open Label Extension Study
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maintenance of or reduction in CDAI score
Secondary outcome: Maintenance of or improvement in safety assessments
Detailed description:
By following the 2 groups of subjects, i. e, those who originally received the test
formulation (80 mg DR-6MP) and are now continuing for another 12 weeks on test drug vs.
those who received the reference drug (Purinethol, 1-1. 5 mg/kg daily) and are now being
introduced to 12 weeks of 80 mg DR6MP test drug, and monitoring the CDAI scores, immunology
parameters (ex. ESR and CRP) and safety assessments (i. e., adverse events occurrences,
weight changes, laboratory test results) and comparing to the parameters at extension study
start, the study will effectively answer the following questions:
1. Does an additional 12 weeks of 80 mg DR6MP test drug treatment maintain or improve CDAI
scores?
2. Is an additional 12 weeks of 80 mg DR6MP test drug treatment safer due to negligible
drug availability systemically?
3. Can an additional 12 weeks of 80 mg DR6MP test drug treatment evoke a more effective
immunological systemic response?
4. In the subset of subjects willing to undergo colonoscopy/ileoscopy, does an additional
12 weeks of 80 mg DR6MP test drug induce effective mucosal healing?
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male and (non-pregnant) female subjects, who completed Protocol C2/13/DR-6MP-02, aged
18-75 years (inclusive)with no serious adverse events or complications and with the
consent of the PI
2. Study entry screening laboratory tests must meet the following criteria:
WBC greater than or equal to 3000mm3 ALT, AST less than 2 x upper limit of normal
Total and direct bilirubin less than 2 x upper limit of normal Note: induction study
Protocol C2/13/DR6MP-02 Week 12 termination labs can serve as screening labs for the
extension study provided that the subject enters the extension study within 2 weeks
of completing the induction study. If the interval is longer, however, repeat
screening labs must be conducted.
3. Subjects must agree not to be taking any treatment for Crohn's disease other than
stable dose of 5-ASA, chronic antibiotics or low-dose oral steroids (prednisolone up
to 15 mg daily; budesonide up to 6 mg daily) at extension study entry and throughout
the study.
4. Subjects willing and able to provide written informed consent.
Exclusion Criteria:
1. Subjects with a body weight at extension study entry below 42. 5 kg
2. Women who are pregnant or nursing at the time of extension study entry or who intend
to be during the study period
3. Women of childbearing potential who do not practice an acceptable method of birth
control [acceptable methods of birth control are: surgical sterilization,
intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable
contraceptive, partner's vasectomy, a double-protection method (condom or diaphragm
with spermicide) or abstinence]
4. Subjects with planned elective surgery or hospitalization during the course of the
study (that may interfere with study compliance or outcome)
5. Subjects who will be unavailable for the duration of the trial, are unable to comply
with the planned schedule of study visits, are likely to be noncompliant with the
protocol, or who are felt to be unsuitable by the investigator for any other reason.
Locations and Contacts
Additional Information
Starting date: October 2011
Last updated: March 5, 2013
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