Hepatitis CPhase 3NCT00040027
Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
A Phase 3 study testing thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a in people with Hepatitis C and Hepatitis C, Chronic, run by SciClone Pharmaceuticals at 48 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Hepatitis C, Chronic
- What is being tested?
- thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Apr 2002to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Age over 18 years old.
- Presence of HCV RNA measured by qualitative PCR.
- Nonresponder to a previous course of therapy with either IFN alone or IFN plus ribavirin. The patient must have been treated for at least 12 weeks.
- Washout period of at least 6 months from previous therapy with IFN alone or IFN plus Ribavirin.
- Liver biopsy consistent with chronic hepatitis C within the last 12 months before treatment starts, and at least 6 months after the end of the prior failed therapy.
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- No clinical or histological evidence of cirrhosis (METAVIR fibrosis score 0 to 3).
- Compensated liver disease with prothrombin time prolonged less than 3 seconds over control, serum albumin stable and within normal limits, total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy, esophageal varices or ascites.
- Ultrasound, CT scan, or MRI of the liver within 3 months of entry negative for HCC.
- Hematocrit > 30%, platelet count > 100 x 109/L, WBC > 3 x 109/L, and polymorphonuclear white cell count > 1.5 x 109/L.
- Adequate renal function as demonstrated by serum creatinine level < 2.0 mg/dL.
- Normal TSH or adequately controlled thyroid function.
- If the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal.
Who cannot join
- Use of systemic corticosteroids within 6 months of entry.
- Current use of any drug known to be hepatotoxic, any drug (other than the study drugs) known to have or suspected of having therapeutic activity in hepatitis C or of any immunosuppressive drug (including corticosteroids).
- Any other liver disease including hepatitis B, hepatitis delta, alcoholic liver disease, drug-induced liver injury, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease.
- Alpha-fetoprotein > 200 ng/mL.
- Current or past diagnosis of cirrhosis.
- Evidence of portal hypertension either by Doppler ultrasonography or gastrointestinal endoscopy.
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- Decompensated liver disease based on a history of hepatic encephalopathy, esophageal varices, or ascites.
- HIV infection diagnosed by HIV seropositivity and confirmed by Western blot.
- Concomitant or prior history of malignancy other than curatively treated skin cancer or surgically cured in situ carcinoma of the cervix.
- Active infectious process other than HCV that is not of a self-limited nature (eg. TB or AIDS).
- Rheumatoid arthritis or other autoimmune disease (serum ANA > 1:160).
- Pregnancy as documented by a urine pregnancy test.
- Alcohol or intravenous drug abuse within the previous 1 year.
- Chronic use of methadone.
- Patients who are poor medical risk or who have any non-malignant systemic disease that, in the opinion of the investigator, would make it unlikely that the patient could complete the protocol.
- Patients with a history of severe depression that required either hospitalization or electroshock therapy; or depression associated with suicide attempt.
- Patients with significant pre-existing cardiac or pulmonary disease.
- Any indication that the patient would not comply with the conditions of the study protocol.
- Previous treatment with thymosin alpha 1.
- Patients with known hypersensitivity to IFNa.
- Simultaneous participation in another investigational drug study, or participation in any clinical trial involving investigational drugs with 3 months before study entry.
- Family history of intracerebral hemorrhage.
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States46 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia
Johns Hopkins University
Baltimore, Maryland
Gastroenterology Associates of East Bay Medical Group
Berkeley, California
New England Medical Center
Boston, Massachusetts
Carolinas Center for Liver Diseases
Charlotte, North Carolina
Chevy Chase Clinical Research
Chevy Chase, Maryland
University of Chicago Hospital & Clinic
Chicago, Illinois
University of Cincinnati - College of Medicine
Cincinnati, Ohio
Metro Health Medical Center, GI Division
Cleveland, Ohio
Baylor University Medical Center
Dallas, Texas
University of Texas Southwestern Medical Center
Dallas, Texas
Duke University Medical Center
Durham, North Carolina
Metropolitan Research
Fairfax, Virginia
University of Florida
Gainesville, Florida
Baylor, VAMC
Houston, Texas
Mississippi Gastrointestinal Associates
Jackson, Mississippi
Mayo Clinic
Jacksonville, Florida
VAMC
Kansas City, Missouri
Scripps Clinic
La Jolla, California
Cedars-Sinai Medical Center
Los Angeles, California
Hepatitis C Treatment Centers, Inc.
Louisville, Kentucky
Liver Research Center - University of Louisville
Louisville, Kentucky
North Shore University Hospital
Manhasset, New York
GI Center MidSouth
Memphis, Tennessee
University of Tennessee Gastroenterology
Memphis, Tennessee
Idaho Gastroenterology Associates
Meridian, Idaho
University of Miami Center for Liver Diseases
Miami, Florida
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin
University of Alabama - Knollwood Physician's Group Bldg.
Mobile, Alabama
Louisiana State University Healthcare Network
New Orleans, Louisiana
Bronx VA Medical Center
New York, New York
NY VAMC
New York, New York
NYU Hospitals Center
New York, New York
University of Pennsylvania Hospital
Philadelphia, Pennsylvania
Oregon Health Sciences University
Portland, Oregon
Roger Williams Medical Center
Providence, Rhode Island
McGuire Research Institute
Richmond, Virginia
William Beaumont Hospital
Royal Oak, Michigan
California Pacific Medical Center
San Francisco, California
Veterans Administration Medical Center GI Section (111B)
San Francisco, California
Center for Digestive and Liver Health
Savannah, Georgia
Mayo Clinic
Scottsdale, Arizona
Saint Louis University Hospital
St Louis, Missouri
Walter Reed Army Medical Center
Washington D.C., District of Columbia
Washington Hospital Center
Washington D.C., District of Columbia
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts
Puerto Rico2 sites
Ponce School of Medicine
Ponce
Fundacion de Investigacion de Diego
Santurce
About this study
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.
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Being tested
- thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a, placebo + PEGinterferon alfa-2a
- Keywords
- hepatitis C, hepatitis C, chronic
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2aDrug
placebo + PEGinterferon alfa-2aDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2002 (estimated)
- Study startApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- SciClone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040027
- Sponsor's protocol ID
- Ta1-CHC-2K0803a
- Status last verified
- Jan 2008
- First submitted
- 18 Jun 2002
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin
- ClinicalTrials.gov ID
- NCT00040027
- Acronym / sponsor ID
- Ta1-CHC-2K0803a
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Keywords
- hepatitis C, hepatitis C, chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- SciClone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- First posted
- 4 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed written informed consent.
- Age over 18 years old.
- Presence of HCV RNA measured by qualitative PCR.
- Nonresponder to a previous course of therapy with either IFN alone or IFN plus ribavirin. The patient must have been treated for at least 12 weeks.
- Washout period of at least 6 months from previous therapy with IFN alone or IFN plus Ribavirin.
Key exclusion criteria (22 listed)
- Use of systemic corticosteroids within 6 months of entry.
- Current use of any drug known to be hepatotoxic, any drug (other than the study drugs) known to have or suspected of having therapeutic activity in hepatitis C or of any immunosuppressive drug (including corticosteroids).
- Any other liver disease including hepatitis B, hepatitis delta, alcoholic liver disease, drug-induced liver injury, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease.
- Alpha-fetoprotein > 200 ng/mL.
- Current or past diagnosis of cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a | Drug | – |
| placebo + PEGinterferon alfa-2a | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing thymalfasin (thymosin alpha 1) + PEGinterferon alfa-2a in people with Hepatitis C and Hepatitis C, Chronic, run by SciClone Pharmaceuticals at 48 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2008.