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Sponsored by: |
SciClone Pharmaceuticals |
---|---|
Information provided by: | SciClone Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00514631 |
The study drug being tested is called SCV-07. SCV-07 is an investigational drug that is being tested to treat diseases such as hepatitis C. SCV-07 may help the body fight infections by increasing immune system activity. So far, in the United States, SCV-07 has been tested in humans as an injection, as a pill you swallow and as a solution absorbed under the tongue. The purpose of this study is to look at the safety of SCV-07 and antiviral effects of different doses of SCV-07 that is injected daily for 7 days to patients with genotype 1 chronic hepatitis C.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: SCV-07 Drug: Control Vehicle |
Phase II |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A PHASE 2a MULTICENTER, RANDOMIZED, CONTROLLED, SINGLE-BLIND DOSE RANGING STUDY TO EVALUATE THE SAFETY AND ANTIVIRAL EFFECT OF SCV-07 IN NON-CIRRHOTIC SUBJECTS WITH GENOTYPE 1 CHRONIC HEPATITIS C WHO HAVE RELAPSED TO PREVIOUS TREATMENT |
Estimated Enrollment: | 30 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator
SCV-07
|
Drug: SCV-07
Subcutaneous injection, escalating dosage, daily for seven days
|
Arm 2: Placebo Comparator
Control Vehicle
|
Drug: Control Vehicle
Subcutaneous injection, daily for seven days
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
United States, California | |
Scripps Clinic | |
La Jolla, California, United States, 93037 | |
United States, Colorado | |
Arapahoe Gastroenterology | |
Littleton, Colorado, United States, 80120 | |
United States, District of Columbia | |
Washington Hospital Center-MedStar Research Institute | |
Washington, District of Columbia, United States, 20010 | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States, 20307 | |
United States, Illinois | |
Accelovance | |
Peoria, Illinois, United States, 61602 | |
United States, Kansas | |
Kansas Medical Clinic | |
Topeka, Kansas, United States, 66606 | |
United States, Kentucky | |
University of Louisville, Liver Research Center | |
Louisville, Kentucky, United States, 40202 | |
United States, Maryland | |
The Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21205 | |
United States, Michigan | |
Henry Ford Medical Center-Columbus | |
Novi, Michigan, United States, 48377 | |
United States, Missouri | |
Saint Louis University School of Medicine | |
St. Louis, Missouri, United States, 63104 | |
United States, North Carolina | |
Sensenbrenner Primary Care | |
Charlotte, North Carolina, United States, 28277 | |
United States, Ohio | |
University of Cincinnati College of Medicine | |
Cincinnati, Ohio, United States, 45267 | |
Dayton Science Institute | |
Dayton, Ohio, United States, 45415 | |
United States, Texas | |
Liver, Kidney and Internal Medicine Center | |
Houston, Texas, United States, 77028 | |
University of Texas Medical Branch | |
Galveston, Texas, United States, 77555-0764 | |
United States, Virginia | |
Hunter Holmes McGuire VAMC | |
Richmond, Virginia, United States, 233249 |
Responsible Party: | SciClone Pharmaceuticals, Inc. ( Israel Rios, MD ) |
Study ID Numbers: | SCI-SCV-HCV-P2a-001 |
Study First Received: | August 8, 2007 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00514631 History of Changes |
Health Authority: | United States: Food and Drug Administration |
SCV-07 and Hepatitis C |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis, Viral, Human Hepatitis C Antiviral Agents Hepatitis C, Chronic |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Flaviviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |