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Study of Sargramostim in Moderately to Severely Active Crohn's Disease

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Sargramostim (Leukine) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

The purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo, in patients with moderately to severely active Crohn's disease.

Clinical Details

Official title: Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 4 Weeks, and Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: CDAI [Crohn's Disease Active Index] improvements

Secondary outcome:

PRO [Patient-reported outcome] variables (QOL [Quality of life]

PGI-C [Patient global impression of change])

Detailed description: On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Confirmed diagnosis of Crohn's disease (endoscopic or radiological evaluation) at

least 4 months prior to receiving the first dose of study drug

- Moderately to severely active Crohn's disease at time of screening (i. e., Crohn's

disease activity index [CDAI] >220 and <475 points) Exclusion Criteria:

- Colostomy or ileostomy

- Immediate need for gastrointestinal (GI) surgery for active GI bleeding, peritonitis,

intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage

- GI surgery within 6 months prior to receiving the 1st dose of study drug

- Symptoms of bowel obstruction or confirmed evidence of a clinically-significant

stricture within the last 6 months that has not been surgically corrected

Locations and Contacts

Additional Information

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Starting date: June 2006
Last updated: December 2, 2013

Page last updated: August 23, 2015

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