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| Sponsor: | 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 |
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| Contact: Ruth Dye | 650-358-3456 | rdye@sciclone.com |
| Contact: Kham Phenis | 650-358-3456 | kphenis@sciclone.com |
| United States, California | |
| Scripps Clinic | Recruiting |
| La Jolla, California, United States, 93037 | |
| Principal Investigator: Paul Pockros, MD | |
| United States, Colorado | |
| Arapahoe Gastroenterology | Recruiting |
| Littleton, Colorado, United States, 80120 | |
| Contact: Marylynn Baker 303-279-1550 | |
| Principal Investigator: Bahri Bilir, MD | |
| United States, District of Columbia | |
| Washington Hospital Center-MedStar Research Institute | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Principal Investigator: Averell Sherker, MD | |
| Walter Reed Army Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20307 | |
| Principal Investigator: Maria Sjogren, MD | |
| United States, Illinois | |
| Accelovance | Recruiting |
| Peoria, Illinois, United States, 61602 | |
| Contact: Sharon Thompson 309-672-1910 ext 122 | |
| Principal Investigator: Kenneth Camacho, MD | |
| United States, Kansas | |
| Kansas Medical Clinic | Recruiting |
| Topeka, Kansas, United States, 66606 | |
| Contact: Kim Scott 785-354-8518 ext 313 | |
| Principal Investigator: Sheckhar Challa, MD | |
| United States, Kentucky | |
| University of Louisville, Liver Research Center | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: Craig McClain, MD | |
| United States, Maryland | |
| The Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: Paul Thuluvath, MD | |
| United States, Michigan | |
| Henry Ford Medical Center-Columbus | Recruiting |
| Novi, Michigan, United States, 48377 | |
| Contact: Nancy Wulbrecht 248-344-2356 | |
| Principal Investigator: Stuart Gordon, MD | |
| United States, Missouri | |
| Saint Louis University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63104 | |
| Principal Investigator: Adrian DiBisceglie, MD | |
| United States, North Carolina | |
| Sensenbrenner Primary Care | Recruiting |
| Charlotte, North Carolina, United States, 28277 | |
| Principal Investigator: John Sensenbrenner, MD | |
| United States, Ohio | |
| University of Cincinnati College of Medicine | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Principal Investigator: Kenneth Sherman, MD | |
| Dayton Science Institute | Recruiting |
| Dayton, Ohio, United States, 45415 | |
| Contact: Gliceria Guerrero 937-293-4424 | |
| Principal Investigator: Patrick Teressa, MD | |
| United States, Texas | |
| Liver, Kidney and Internal Medicine Center | Recruiting |
| Houston, Texas, United States, 77028 | |
| Contact: Leticia Foronda 713-851-0698 | |
| Principal Investigator: Brian Lipsen, MD | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77555-0764 | |
| Contact: Dedra Hicks 409-772-8209 | |
| Principal Investigator: Ned Snyder, MD | |
| United States, Virginia | |
| Hunter Holmes McGuire VAMC | Recruiting |
| Richmond, Virginia, United States, 233249 | |
| Principal Investigator: Douglas Heuman, MD | |
More Information
| Responsible Party: | SciClone Pharmaceuticals, Inc. ( Israel Rios, MD ) |
| Study ID Numbers: | SCI-SCV-HCV-P2a-001 |
| Study First Received: | August 8, 2007 |
| Last Updated: | October 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00514631 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
SCV-07 and Hepatitis C |
|
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Flaviviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
