Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9

NCT00575224 | Completed Phase 4

• 3 other identifiers: PEG-183IRB Protocol #20041038IRB Study #1059635
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients are randomly assigned (by chance) to either Treatment Group A (Pegasys and Copegus for 24 weeks) or Treatment Group B (Pegasys and Copegus for 48 weeks).

Conditions

Chronic Hepatitis C; Asian Americans; Novel Genotypes; Treatment

Keywords

Hepatitis C; Genotype 6; Novel genoytpe; HCV; Treatment

Outcome Measures

Primary Outcomes (1)

• Sustained virologic response

  24 weeks post-treatment

Study Arms (2)

A

OTHER

Pegylated interferon and ribavirin for 24 weeks

Drug: Pegylated interferon and ribavirin

B

OTHER

Pegylated interferon and ribavirin for 48 weeks

Drug: Pegylated interferon and ribavirin

Interventions

Pegylated interferon and ribavirin DRUG

180 ug of peg-IFN per week and 1000-1200 mg of ribavirin per day (weight-dependent). Treatment duration is determined by treatment arm.

Also known as: Pegasys and Copegus

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must meet the following criteria for entry.
• Subject must be willing to give written informed consent and be able to adhere to dose and visit schedules.
• Adult subjects 18-70 years of age of both gender and any race as long as they have HCV genotype 6, 7, 8, and 9.
• Serum positive for HCV-RNA by PCR (qPCR) assay, or bDNA
• Liver biopsy within 24 months prior to entry to this protocol with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis C with stage II or more fibrosis. Biopsy must be scored or be re-read to score fibrosis stage and grade and severity of steatosis.
• Compensated liver disease with the following minimum hematologic, biochemical, and serologic criteria at the Entry Visit (WNL = within normal limits).
• Hemoglobin (Hb) greater than or equal to12 gm/dL for women and 13 gm/dL for men.
• White blood cell count (WBC) greater than or equal to 2,000/mm3
• Platelets (PLT) greater than or equal to 90,000/mm3
• Direct bilirubin (DB) less than or equal to 1.0
• Indirect bilirubin (IB) = WNL or greater than or equal to 3.0 mg/dL if this is due to non-hepatitis related factors such as Gilbert's disease.
• Creatinine (Cr) clearance greater than or equal to50 mL/minute or serum Cr greater than or equal to 1.5x UNL at screening.
• Fasting glucose (FBS) less than or equal to160 mg/dL and Hb A1c greater than or equal to 8.5% for diabetic subjects (whether on medication or diet controlled).

You may not qualify if:

• Serum anti-HIV = negative
• Serum HBsAg = negative
• Abdominal ultrasound negative for liver masses within 3 months prior to entry. Patients without cirrhosis or transition to cirrhosis may have there imaging studies done within 12 months of study entry.
• Alpha-fetoprotein (AFP) less than or equal to 20 ng/mL obtained within 3 months prior to entry. Patients with 20 ng/mL less than or equal to AFP less than or equal to 100ng/mL may be enrolled after a normal biphasic abdominal CT within the previous 3 months if patients have Stage III/IV fibrosis and after a normal ultrasound if patients have Stage I/II fibrosis. If AFP is more than 100 but less than 200 ng/dL, all patients need to have a negative biphasic CT within 3 months.
• Female subjects must not be breast-feeding.
• A pregnancy test must be obtained within 24 hours to the first dose of study drugs and must be negative.
• Additionally, all fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months after treatment completion.
• Acceptable forms of contraception may include intrauterine device, oral contraceptives, progesterone implanted rods \[Norplant\], medroxyprogesterone acetate \[Depo-Provera\], surgical sterilization, barrier method \[diaphragm + spermicide or condom + spermicide\]
• The subject will be excluded from entry if any of the following criteria apply:
• Women who are pregnant or breast feeding.
• Male partners of women who are pregnant.
• Suspected hypersensitivity to interferon, PEG-interferon or Copegus.
• Treatment with any investigational drug within 45 days of entry to this protocol.
• Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment greater than or equal to6 months prior to the first dose of study drug, except PEG-IFN alfa-2b and ribavirin. This includes amantadine, mycophenolate mofetil, thymosine alpha, viramidine, levovirin, supraphysiologic doses of steroids (greater than or equal to 10 mg/d for greater than or equal to 14 consecutive days of prednisone or equivalence) and radiation, exception: patients who have had a limited (greater than or equal to 7 day) course of acyclovir or valacyclovir for herpetic lesions more than 1 month prior to the first administration of test drug are not excluded.
• Any other cause for the liver disease other than chronic hepatitis C including but not limited to:

Sponsors & Collaborators

• Pacific Health Foundation: lead
• Hoffmann-La Roche: collaborator

Study Sites (5)

San Diego Gastroenterology Clinic

San Diego, California, 92115, United States

Location

San Jose Gastroenterology

San Jose, California, 95116, United States

Location

Westminster Gastroenterology Clinic

Westminster, California, 92843, United States

Location

Houston Gastroenterology Clinic

Houston, Texas, 77072, United States

Location

Digestive Health Associates of Texas

Plano, Texas, 75093, United States

Location

Related Publications (16)

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• Mizokami M, Gojobori T, Ohba K, Ikeo K, Ge XM, Ohno T, Orito E, Lau JY. Hepatitis C virus types 7, 8 and 9 should be classified as type 6 subtypes. J Hepatol. 1996 May;24(5):622-4. doi: 10.1016/s0168-8278(96)80149-8.

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• Hui CK, Yuen MF, Sablon E, Chan AO, Wong BC, Lai CL. Interferon and ribavirin therapy for chronic hepatitis C virus genotype 6: a comparison with genotype 1. J Infect Dis. 2003 Apr 1;187(7):1071-4. doi: 10.1086/368217. Epub 2003 Mar 7.

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MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mindie H Nguyen, M.D., M.A.S.

  Stanford University Medical Center and Pacific Health Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2007
• First Posted: December 18, 2007
• Study Start: October 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

US (5)