Open Label Extension Study to Protocol C2/13/DR-6MP-02

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01433432
• Date of registration: 12/09/2011
• Prospective Registration: Yes
• Primary sponsor: Teva GTC
• Public title: Open Label Extension Study to Protocol C2/13/DR-6MP-02 OLE
• Scientific 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
• Date of first enrolment: October 2011
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01433432
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Israel

Contacts

• Name: Eran Goldin, MD
• Affiliation: Shaare Zedek Medical Center

• Name: Yaron Ilan, MD
• Affiliation: Hadassah Medical Center

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: 80 mg DR-6MP

Primary Outcome(s)

Maintenance of or reduction in CDAI score [Time Frame: 12 weeks]

Secondary Outcome(s)

Maintenance of or improvement in safety assessments [Time Frame: 12 weeks]

Secondary ID(s)

C2/13/DR-6MP-02 EXT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors