An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
Status: | Recruiting |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/31/2019 |
Start Date: | January 14, 2019 |
End Date: | December 17, 2022 |
Contact: | Reference Study ID Number: GA40209 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. Only) |
A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease
This study will evaluate the long-term safety and tolerability of UTTR1147A in participants
with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320
participants from the Phase Ib Study GA29469 and Phase II Study GA39925 (parent studies).
with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320
participants from the Phase Ib Study GA29469 and Phase II Study GA39925 (parent studies).
Inclusion Criteria:
- Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entry
criteria
- Ability to comply with requirements of the study, in the investigator's judgment
- For women and men: use of highly effective contraception as defined by the protocol.
Exclusion Criteria:
- Withdrawal of consent from parent study
- Discontinuation of study drug as required by the parent study protocol
- Noncompliance in the parent study, specifically defined as missing scheduled visits or
non-adherence with background medications and concomitant medications
- Pregnant or breastfeeding, or intending to become pregnant during the study or within
8 weeks after the final dose of study drug or within 18 weeks after the final dose of
study drug from GA39925, whichever is longer
- Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary,
renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms of
infection judged by the investigator to be clinically significant since enrolling in
the parent study
- Use of prohibited therapies as defined in the parent study
- Abnormal laboratory value recorded at the last visit in the parent study
We found this trial at
21
sites
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Miami A private research university with more than 15,000 students from around the...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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