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Chronic Hepatitis CPhase 4NCT00575224

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

A Phase 4 study testing Pegylated interferon and ribavirin in people with Chronic Hepatitis C and Asian Americans, run by Pacific Health Foundation at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pegylated interferon and ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesUnited States
Study dates
Oct 2004to Sep 2009
Phase
Phase 4
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

  • 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).
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  • 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).
  • Thyroid Stimulating Hormone (TSH) = WNL (Subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met.)
  • 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]

Who cannot join

  • 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.
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  • Any other cause for the liver disease other than chronic hepatitis C including but not limited to:
  • Co-infection with HBV
  • Hemochromatosis (iron deposition greater than or equal to2+ or severe in liver parenchyma)
  • Alpha-1 antitrypsin deficiency
  • Wilson's disease
  • Autoimmune hepatitis
  • Alcoholic liver disease
  • Significant obesity-induced liver disease (elevated ALT with BMI greater than or equal to 30)
  • Drug-related liver disease
  • Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy.
  • Hemoglobinopathies (e.g., Thalassemia) with significant anemia.
  • History or other evidence of decompensated liver disease or a Child-Pugh score 6. Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease.
  • Patients with history of hepatocellular carcinoma.
  • Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as:
  • A history of preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded. Severe depression would include the following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject's mental status supports that the subject is clinically stable. The Investigator will formulate a management plan for each of the subjects that will become a part of the subject's medical record. The management plans may be developed in conjunction with a health care professional trained in psychology. For these subjects, the Investigator will review the subject's mental status at every visit.
  • CNS trauma or active seizure disorders requiring medication.
  • Significant cardiovascular dysfunction within the past 12 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe uncontrolled hypertension or significant arrhythmia). Subjects with ECG showing clinically significant abnormalities.
  • Poorly controlled diabetes mellitus.
  • Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease), documented pulmonary hypertension.
  • Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, clinical cryoglobulinemia with vasculitis).
  • Clinical gout.
  • Any patient with an increased baseline risk for anemia (e.g. thalassemia other than thalassemia trait, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
  • Patients in whom, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin therapy) would not be well-tolerated.
  • History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.)
  • History of major organ transplantation with an existing functional graft
  • Substance abuse, such as alcohol (greater than or equal to 80 gm/day), IV drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 12 months. Stable subjects enrolled in a methadone maintenance program for at least one year may be enrolled if they are otherwise eligible and are monitored throughout the study for illicit drug use.
  • Subjects not willing to abstain from the consumption of alcohol.
  • Subjects with severe retinopathy (e.g. CMV retinitis, macular degeneration) or clinically significant retinal abnormalities.
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study.
  • Any other condition, which in the opinion of the Investigators would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Houston Gastroenterology Clinic

    Houston, Texas, 77072

  • Digestive Health Associates of Texas

    Plano, Texas, 75093

  • San Diego Gastroenterology Clinic

    San Diego, California, 92115

  • San Jose Gastroenterology

    San Jose, California, 95116

  • Westminster Gastroenterology Clinic

    Westminster, California, 92843

Other trials in United States

About this study

Official title: Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9: a Phase IV, Randomized, Open-labeled, Multicenter Trial Comparing 24-week vs. 48-week Therapy

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).

Being tested
Pegylated interferon and ribavirin
Keywords
Hepatitis C, Genotype 6, Novel genoytpe, HCV, Treatment
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pegylated interferon and ribavirinDrug

    Also called Pegasys and Copegus

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

Study groups in NCT00575224
Study groupRoleWhat they receive
AOtherPegylated interferon and ribavirin for 24 weeks
Receives: Drug: Pegylated interferon and ribavirin
BOtherPegylated interferon and ribavirin for 48 weeks
Receives: Drug: Pegylated interferon and ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained virologic response

    Measured: 24 weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2007 (estimated)
  2. Study startOct 2004
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00575224
Sponsor's protocol ID
PEG-183
Other IDs
IRB Protocol #20041038, IRB Study #1059635
Status last verified
Nov 2009
First submitted
15 Dec 2007
Last updated
25 Nov 2009
Results posted
No
Data monitoring committee
No

Publications

  • Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.

    PubMed 10451460

  • Adams NJ, Chamberlain RW, Taylor LA, Davidson F, Lin CK, Elliott RM, Simmonds P. Complete coding sequence of hepatitis C virus genotype 6a. Biochem Biophys Res Commun. 1997 May 19;234(2):393-6. doi: 10.1006/bbrc.1997.6627.

    PubMed 9177282

  • Nguyen MH, Keeffe EB. Prevalence and treatment of hepatitis C virus genotypes 4, 5, and 6. Clin Gastroenterol Hepatol. 2005 Oct;3(10 Suppl 2):S97-S101. doi: 10.1016/s1542-3565(05)00711-1.

    PubMed 16234071

  • 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.

    PubMed 8773919

  • Nguyen MH, Keeffe EB. Chronic hepatitis C: genotypes 4 to 9. Clin Liver Dis. 2005 Aug;9(3):411-26, vi. doi: 10.1016/j.cld.2005.05.010.

    PubMed 16023974

  • Lu L, Nakano T, He Y, Fu Y, Hagedorn CH, Robertson BH. Hepatitis C virus genotype distribution in China: predominance of closely related subtype 1b isolates and existence of new genotype 6 variants. J Med Virol. 2005 Apr;75(4):538-49. doi: 10.1002/jmv.20307.

    PubMed 15714489

  • Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82. doi: 10.1056/NEJMoa020047.

    PubMed 12324553

  • Lindsay KL. Introduction to therapy of hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S114-20. doi: 10.1053/jhep.2002.36226.

    PubMed 12407584

  • Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.

    PubMed 11583749

  • Kinzie JL, Naylor PH, Nathani MG, Peleman RR, Ehrinpreis MN, Lybik M, Turner JR, Janisse JJ, Massanari M, Mutchnick MG. African Americans with genotype 1 treated with interferon for chronic hepatitis C have a lower end of treatment response than Caucasians. J Viral Hepat. 2001 Jul;8(4):264-9. doi: 10.1046/j.1365-2893.2001.00292.x.

    PubMed 11454177

  • Muir A, Rockey DC. Treatment of acute hepatitis C with interferon alfa-2b. N Engl J Med. 2002 Apr 4;346(14):1091-2. No abstract available.

    PubMed 11936122

  • Reddy KR, Hoofnagle JH, Tong MJ, Lee WM, Pockros P, Heathcote EJ, Albert D, Joh T. Racial differences in responses to therapy with interferon in chronic hepatitis C. Consensus Interferon Study Group. Hepatology. 1999 Sep;30(3):787-93. doi: 10.1002/hep.510300319.

    PubMed 10462387

  • Wiley TE. Hepatitis C: does race really matter? Am J Gastroenterol. 2001 Aug;96(8):2292-4. doi: 10.1111/j.1572-0241.2001.04030.x. No abstract available.

    PubMed 11513163

  • 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.

    PubMed 12660921

  • Dev AT, McCaw R, Sundararajan V, Bowden S, Sievert W. Southeast Asian patients with chronic hepatitis C: the impact of novel genotypes and race on treatment outcome. Hepatology. 2002 Nov;36(5):1259-65. doi: 10.1053/jhep.2002.36781.

    PubMed 12395338

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pegylated interferon and ribavirin in people with Chronic Hepatitis C and Asian Americans, run by Pacific Health Foundation at 5 sites in United States.

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 22 inclusion and 36 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 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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.

What does the primary outcome measure?

Sustained virologic response (time frame: 24 weeks post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00575224, which also lists 16 linked publications.

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 25 Nov 2009.

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