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Trial record 12 of 309 for:    Open Studies | "Hepatitis C"

Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Turin, Italy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00575627
First received: December 14, 2007
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

Patients with chronic hepatitis C with persistently normal alanine aminotransferase (ALT) levels have been generally excluded from treatment, because the strong conviction that normal ALT would be synonymous of absence of liver damage. However, recent studies have demonstrated marked liver fibrosis, including cirrhosis, in patients with HCV and persistently normal ALT levels. Up to now, just a sigle randomized, controlled, multicenter study was lead to evaluate the efficacy and safety of combined therapy in patients with chronic hepatitis C and persistently normal serum ALT levels. Aim of our study is evaluate the efficacy of treatment and the outcome of treated patients compared with a control group of untreated patients.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Peg-Interferon alpha2a plus Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Chronic Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels With Peginterferon α-2a (40 kDa) Plus Ribavirin

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • To evaluate the efficacy of treatment and the outcome of treated patients compared with a control group of untreated patients. [ Time Frame: 48-72 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evaluation of liver fibrosis by Fibroscan after 48-72 weeks of inclusion [ Time Frame: 48-72 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2
Experimental: 1
Drug: peginterferon α-2a (40 kDa) plus ribavirin for 24-48 weeks
Drug: Peg-Interferon alpha2a plus Ribavirin
Peg-Interferon alpha2a: 180 micrograms per week Ribavirin:100-1200 mg/daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serologic evidence of chronic hepatitis C infection (repeatedly HCV-RNA positive) with persistent normal ALT levels documented on at least 3 occasions, in the last 18 months before screening.
  • Fibroscan performed in the last 3 months
  • Compensated liver disease, Child Pugh score <7
  • Serum HCV-RNA >615 IU/mL
  • Patients who are naïve to any hepatitis C therapy (i.e. have not been previously treated with an interferon or with IFN plus ribavirin)
  • No clinical or radiological evidence of hepatocellular carcinoma and a serum AFP <100 ng/mL within 2 months of randomisation
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
  • All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • History or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease (Child Pugh B or C)
  • Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) £6 months prior to the first dose of study drug
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
  • Serum creatinine level >1.5 times the upper limit of normal at screening
  • Evidence of current severe psychiatric disease, especially depression within one year of study entry. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, within 12 months prior to study entry. Patients with a previous history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease should be evaluated by a qualified Psychiatrist for study suitability prior to enrolment.
  • History of a severe seizure disorder or current anticonvulsant use History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
  • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
  • Evidence of drug abuse (including excessive alcohol consumption) within 6 months of study entry
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study
  • Male partners of women who are pregnant
  • Hgb <12 g/dL in women or <13 g/dL in men at screening
  • Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575627

Contacts
Contact: RIZZETTO Mario, MD +39-011-6336397 m.rizzetto@molinette.piemonte.it
Contact: CIANCIO Alessia, MD, PhD +39-011-6336224 aciancio3@molinette.piemonte.it

Locations
Italy
Università degli Studi di Torino - Azienda Ospedaliera San Giovanni Battista di Torino, Molinette, Recruiting
Torino, Italy, 10126
Contact: Ciancio Alessia, MD, PhD    +39-0116336224    aciancio3@molinette.piemonte.it   
Principal Investigator: Ciancio Alessia, MD, PhD         
Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: Rizzetto Mario Università degli Studi di Torino - Azienda Ospedaliera San Giovanni Battista di Torino, Molinette,
  More Information

No publications provided

Responsible Party: Prof Mario Rizzetto - Dipartimento di GastroEpatologia - Università degli Studi di Torino, Università degli Studi di Torino
ClinicalTrials.gov Identifier: NCT00575627     History of Changes
Other Study ID Numbers: pNNALTHCV, NNALT
Study First Received: December 14, 2007
Last Updated: June 3, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by University of Turin, Italy:
Hepatitis C
persistently normal ALT
pNNALT
Theraphy for Hepatitis C
Pegylated Interferon
Combined therapy

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014