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Phase 3
18 Years
N/A
Not Enrolling
Both
Hepatitis C, Hepatitis C, Chronic

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Trial Information

Inclusion Criteria


Inclusion criteria:

- 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 3 months (12 weeks).

- Washout period of at least 6 months from previous therapy with IFN alone or IFN plus
Ribavirin.

- Liver biopsy consistent with cirrhosis or progression to cirrhosis (METAVIR fibrosis
score 3 to 4) due to chronic hepatitis C within the last 12 months before treatment
starts, and at least 6 months after the end of the prior failed therapy.

- Cirrhosis classified as Child-Pugh "A" (no more than 6 points).

- Compensated liver disease with prothrombin time prolonged less than 3 seconds over
control, total bilirubin < 2 mg/dl, and no history of hepatic encephalopathy,
bleeding varices or a history of detection of stigmata of recent bleeding on existing
varices or ascites.

- Ultrasound, CT scan, or MRI of the liver within 3 months of entry negative for HCC.

- Hematocrit > 30%, platelet count > 75,000, WBC > 2,500, and absolute neutrophil cell
count > 1,500.

- 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.

Exclusion criteria:

- Use of systemic corticosteroids within 6 months of entry.

- Evidence of drug-induced liver injury.

- Current use of any drug known to have or suspected of having therapeutic activity in
hepatitis C, or any immunosuppressive drug (including corticosteroids).

- Evidence of any other liver disease including hepatitis B, hepatitis delta, alcoholic
liver disease, primary biliary cirrhosis, sclerosing cholangitis, autoimmune
hepatitis, hemochromatosis, alpha 1-antitrypsin deficiency, or Wilson's disease.

- Alpha-fetoprotein > 200 ng/mL.

- Child-Pugh "B" or "C" cirrhosis (score of 7 or more points), either currently or at
any occasion in the past.

- Decompensated liver disease based on a history of hepatic encephalopathy, bleeding
varices or a history of detection of stigmata of recent bleeding on existing 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.

- 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.

- Recipients of transplants.

- Patients with uncontrolled seizure disorder.

- 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 IFN a.

- Simultaneous participation in another investigational drug study, or participation in
any clinical trial involving investigational drugs within 3 months of study entry.

- Family history of intracerebral hemorrhage.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

Ta1-CHC-2K0804

NCT ID:

NCT00039962

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Hepatitis C
  • Hepatitis C, Chronic
  • hepatitis C
  • hepatitis C, chronic
  • cirrhosis, liver
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Hepatitis C, Chronic

Name

Location

Baylor College of MedicineHouston, Texas  77030
Johns Hopkins UniversityBaltimore, Maryland  21205
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Loma Linda University Medical CenterLoma Linda, California  92354
North Shore University HospitalManhasset, New York  11030
Scripps ClinicLa Jolla, California  92037
William Beaumont HospitalRoyal Oak, Michigan  48073
Mayo ClinicJacksonville, Florida  32224
Huntington Memorial HospitalPasadena, California  91109-7013
Washington Hospital CenterWashington, District of Columbia  20010
Advanced Clinical Research InstituteAnaheim, California  92801
Wisconsin Center for Advanced ResearchMilwaukee, Wisconsin  53207
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Duke University Medical CenterDurham, North Carolina  27710
Oregon Health Sciences UniversityPortland, Oregon  
University of FloridaGainesville, Florida  32610-0277
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
McGuire DVAMCRichmond, Virginia  23249
California Pacific Medical CenterSan Francisco, California  94115
University of LouisvilleLouisville, Kentucky  40202
University of Alabama - Knollwood Physician's GroupMobile, Alabama  
Mayo ClinicScottsdale, Arizona  
Gastroenterology Associates of East Bay Medical GroupBerkeley, California  
Kaiser PermanenteSacramento, California  
University of California, Davis Medical CenterSacramento, California  
San Mateo Medical CenterSan Mateo, California  
Arapahoe GastroenterologyLittleton, Colorado  
University Of Miami Center for Liver DiseasesMiami, Florida  
Digestive Healthcare of GeorgiaAtlanta, Georgia  
Center for Digestive and Liver HealthSavannah, Georgia  
Idaho Gastroenterology AssociatesMeridian, Idaho  
University of Chicago Hospital & ClinicChicago, Illinois  
LSU Healthcare NetworkNew Orleans, Louisiana  
Chevy Chase Clinical ResearchChevy Chase, Maryland  
Endoscopic Microsurgery AssociatesTowson, Maryland  
New England Medical CenterBoston, Massachusetts  
Mississippi Gastrointestinal AssociatesJackson, Mississippi  
VAMCKansas City, Missouri  
Bradley Freilich MD, LLCKansas City, Missouri  
VA Harbor HealthCare SystemNew York, New York  
NYU Gastroenterology & HepatologyNew York, New York  
Carolinas Center for Liver DiseaseCharlotte, North Carolina  
University of Cincinnati College of MedicineCincinnati, Ohio  
Metro Health Medical Ctr.Cleveland, Ohio  
The Cleveland Clinic FoundationCleveland, Ohio  
Jefferson University PhysiciansPhiladelphia, Pennsylvania  
Advanced Clinical ResearchProvidence, Rhode Island  
University of Tennessee GastroenterologyMemphis, Tennessee  
Austin Gastroenterology PAAustin, Texas  
Baylor University Medical Ctr.Dallas, Texas  
Baylor, VAMCHouston, Texas  
Metropolitan ResearchFairfax, Virginia