- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00038922
Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis
May 17, 2006 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis
To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.
To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented, signed informed consent to participate in this study
- Age greater than or equal to 18 years
- Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy
Exclusion Criteria:
- Crohn's disease
- Ulcerative proctitis
- Ulcerative colitis extending beyond the splenic flexure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 5, 2002
First Submitted That Met QC Criteria
June 6, 2002
First Posted (Estimate)
June 7, 2002
Study Record Updates
Last Update Posted (Estimate)
May 18, 2006
Last Update Submitted That Met QC Criteria
May 17, 2006
Last Verified
May 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3067K5-114
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ulcerative Colitis
-
Ferring PharmaceuticalsCompletedActive Ulcerative Colitis | Remission of Ulcerative ColitisCanada
-
Palatin Technologies, IncRecruitingUlcerative Colitis | Ulcerative Colitis Flare | Ulcerative Colitis Acute | UlcerativeUnited States
-
Theravance BiopharmaCompletedUlcerative Colitis, Active Severe | Ulcerative Colitis, Active ModerateUnited States, Georgia, Moldova, Republic of, Romania
-
Rise Therapeutics LLCUniversity of Colorado, Denver; Mayo ClinicRecruitingUlcerative Colitis | Ulcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic | Ulcerative Colitis Chronic MildUnited States
-
Assistance Publique - Hôpitaux de ParisMRSU 938 - Research Center of Saint AntoineNot yet recruitingPediatric Ulcerative Colitis in RemissionFrance
-
Protagonist Therapeutics, Inc.CompletedUlcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic SevereUnited States, Austria, Bulgaria, Canada, Georgia, Germany, Hungary, Italy, Korea, Republic of, Poland, Russian Federation, Serbia, Ukraine
-
Theravance BiopharmaCompletedActive Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsUnited States
-
Altheus Therapeutics, Inc.UnknownUlcerative Colitis | Left-sided Ulcerative Colitis | Distal Ulcerative ColitisUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...University Medical Center Groningen; UMC UtrechtRecruitingUlcerative Colitis | Ulcerative Colitis Flare | Ulcerative Colitis AcuteNetherlands
-
Immune PharmaceuticalsUnknownUlcerative Colitis, Active Severe | Ulcerative Colitis, Active ModerateIsrael
Clinical Trials on rhIL-11
-
University of PittsburghWyeth is now a wholly owned subsidiary of Pfizer; University of North CarolinaCompleted
-
Shanghai Children's Medical CenterXiamen Amoytop Biotech Co., Ltd.CompletedPancytopenia Due to ChemotherapyChina
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedCrohn Disease | Inflammatory Bowel DiseaseUnited States
-
Beijing Northland Biotech. Co., Ltd.CompletedChemotherapy-induced ThrombocytopeniaChina
-
Liaoning Tumor Hospital & InstituteCompletedChemotherapy-induced ThrombocytopeniaChina
-
Ming HouPeking Union Medical College Hospital; Cancer Institute and Hospital, Chinese... and other collaboratorsWithdrawnPurpura, Thrombocytopenic, IdiopathicChina
-
Cytheris, Inc.CompletedAML | MDS | CMLUnited States
-
Cytheris SACompletedHIV Infections | LymphopeniaUnited States, France, Canada, Italy
-
NeoImmuneTechNational Institute of Allergy and Infectious Diseases (NIAID); University of...Terminated
-
Fudan UniversityUnknownRecurrent Colorectal Carcinoma | Thrombopenia