Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
Public ClinicalTrials.gov record NCT00040027. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Chronic hepatitis C infection is one of the leading causes of chronic liver disease in the United States. Approximately one-third of patients with hepatitis C infection develop cirrhosis of the liver, which can lead to liver failure or liver cancer. The current treatment for hepatitis C infection in previously untreated patients is successful in only about half of patients. There is no established therapy for non-responders. This is a randomized, double-blinded, multicenter trial to determine the effectiveness of thymosin alpha 1 (thymalfasin) 1.6 mg twice weekly plus PEGinterferon alfa-2a 180 ug/wk compared to placebo plus PEGinterferon alfa-2a in adults with chronic hepatitis C without cirrhosis who are non-responders to previous treatment with interferon or interferon plus ribavirin. The definition of non-response requires a positive HCV RNA test at the end of a course of at least 12 weeks of therapy. Patients will receive treatment for 12 months, and will be followed-up for a further 6 months after the end of therapy.
Study identification
- NCT ID
- NCT00040027
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 500 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2002
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Jan 14, 2008
Started 2002
United States locations
- U.S. sites
- 46
- U.S. states
- 25
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Knollwood Physician's Group Bldg. | Mobile | Alabama | — | — |
| Mayo Clinic | Scottsdale | Arizona | — | — |
| Gastroenterology Associates of East Bay Medical Group | Berkeley | California | — | — |
| Scripps Clinic | La Jolla | California | — | — |
| Cedars-Sinai Medical Center | Los Angeles | California | — | — |
| California Pacific Medical Center | San Francisco | California | — | — |
| Veterans Administration Medical Center GI Section (111B) | San Francisco | California | — | — |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | — | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | — | — |
| University of Florida | Gainesville | Florida | — | — |
| Mayo Clinic | Jacksonville | Florida | — | — |
| University of Miami Center for Liver Diseases | Miami | Florida | — | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | — | — |
| Center for Digestive and Liver Health | Savannah | Georgia | — | — |
| Idaho Gastroenterology Associates | Meridian | Idaho | — | — |
| University of Chicago Hospital & Clinic | Chicago | Illinois | — | — |
| Hepatitis C Treatment Centers, Inc. | Louisville | Kentucky | — | — |
| Liver Research Center - University of Louisville | Louisville | Kentucky | — | — |
| Louisiana State University Healthcare Network | New Orleans | Louisiana | — | — |
| Johns Hopkins University | Baltimore | Maryland | — | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | — | — |
| New England Medical Center | Boston | Massachusetts | — | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | — | — |
| William Beaumont Hospital | Royal Oak | Michigan | — | — |
| Mississippi Gastrointestinal Associates | Jackson | Mississippi | — | — |
| VAMC | Kansas City | Missouri | — | — |
| Saint Louis University Hospital | St Louis | Missouri | — | — |
| North Shore University Hospital | Manhasset | New York | — | — |
| Bronx VA Medical Center | New York | New York | — | — |
| NY VAMC | New York | New York | — | — |
| NYU Hospitals Center | New York | New York | — | — |
| Carolinas Center for Liver Diseases | Charlotte | North Carolina | — | — |
| Duke University Medical Center | Durham | North Carolina | — | — |
| University of Cincinnati - College of Medicine | Cincinnati | Ohio | — | — |
| Metro Health Medical Center, GI Division | Cleveland | Ohio | — | — |
| Oregon Health Sciences University | Portland | Oregon | — | — |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | — | — |
| Roger Williams Medical Center | Providence | Rhode Island | — | — |
| GI Center MidSouth | Memphis | Tennessee | — | — |
| University of Tennessee Gastroenterology | Memphis | Tennessee | — | — |
| Baylor University Medical Center | Dallas | Texas | — | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | — | — |
| Baylor, VAMC | Houston | Texas | — | — |
| Metropolitan Research | Fairfax | Virginia | — | — |
| McGuire Research Institute | Richmond | Virginia | — | — |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00040027, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 14, 2008 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00040027 live on ClinicalTrials.gov.