Proof of Concept Study to Determine Efficacy and Safety of SCV-07 in Patients With Chronic Relapsed Hepatitis C - Full Text View

Sponsored by:	SciClone Pharmaceuticals
Information provided by:	SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00514631

Purpose

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

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Golotimod

U.S. FDA Resources

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

Further study details as provided by SciClone Pharmaceuticals:

Primary Outcome Measures:

Safety [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Subjects must be 18 years of age or older.
Subjects must have genotype 1 non-cirrhotic chronic hepatitis C. Relapsed on prior pegylated interferon/ribavirin based therapy No histologic evidence of cirrhosis, as demonstrated by a liver biopsy performed within the last 2 year
HCV RNA titer must be ≥ 600,000 IU/mL.
Participation in another investigational study within 60 days preceding enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514631

Locations

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

Sponsors and Collaborators

SciClone Pharmaceuticals

More Information

Related Info This link exits the ClinicalTrials.gov site

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:

SCV-07 and Hepatitis C

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009