Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection

NCT00248339 | Completed Phase 3 DMC

• 1 other identifier: 1988 WIRB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the use of epoetin-alpha will allow patients with chronic hepatitis C virus infection to be treated with higher doses of peginterferon-alpha-2b and ribavirin, thus increasing chances at lower viral levels and raising sustained virologic response.

Conditions

Hepatitis C

Keywords

Hepatitis C; Peginterferon; Ribavirin; Procrit; Epoetin-alpha

Outcome Measures

Primary Outcomes (1)

• The mean dose of ribavirin utilized in each of the 3 treatment arms will be compared.

  18 months

Secondary Outcomes (3)

• Number of patients in each group who required a dose reduction of ribavirin

  18 months

• Rate of virologic response and sustained virologic response observed in each group

  18 months

• Rate of decline in HCV RNA titer in each group

  18 months

Study Arms (3)

1

ACTIVE COMPARATOR

PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD

Drug: Peginterferon-alpha-2b (PEG-Intron); Drug: Ribavirin

2

ACTIVE COMPARATOR

PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.

Drug: Peginterferon-alpha-2b (PEG-Intron); Drug: Ribavirin; Drug: Epoetin-alpha (Procrit)

3

ACTIVE COMPARATOR

PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.

Drug: Peginterferon-alpha-2b (PEG-Intron); Drug: Ribavirin; Drug: Epoetin-alpha (Procrit)

Interventions

Peginterferon-alpha-2b (PEG-Intron) DRUG

PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.

1; 2; 3

Ribavirin DRUG

PEG-interferon-alpha-2b 1.5 μg/kg QW plus ribavirin \~13.3 mg/kg QD PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.

1; 2; 3

Epoetin-alpha (Procrit) DRUG

PEG-interferon-alpha-2b 1.5 μg/kg QW plus standard dose ribavirin, \~13.3 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week. PEG-interferon-alpha-2b 1.5 μg/kg QW plus high dose ribavirin, \~15.2 mg/kg QD, plus erythropoetin (PROCRIT®) 40,000 U/week.

2; 3

Eligibility Criteria

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

You may qualify if:

• HCV RNA positive in serum
• HCV genotype 1
• Liver histology consistent with chronic HCV performed within 24 months prior to starting medication in this study

You may not qualify if:

• Previous interferon treatment
• Any other cause for liver disease
• Hemoglobin \>10 gm/dl
• WBC \>3,000/cubic mm
• Platelet count \> 80,000/cubic mm
• Serum albumin \< 3.5 gm.dl
• Conjugated serum bilirubin \> 2.0 mg/dl
• INR \> 1.5
• Positive HIV test
• Refusal to use adequate contraception in female subjects or the spouse.sexual partners of male subjects
• An elevation in TSH (thyroid stimulating hormone). Patients with a pre-existing thyroid disorder may enter the study if their TSH level can be maintained within the normal range.
• Women who are pregnant or breast feeding.
• A history of decompensated liver disease defined as presence of ascites, bleeding esophageal or gastric varices or hepatic encephalopathy.
• Patients with active alcohol/drug use.
• Patients with active psychiatric disorders which might be exacerbated by interferon therapy including schizophrenia and severe depression.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (6)

• McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, Goodman ZD, Ling MH, Cort S, Albrecht JK. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med. 1998 Nov 19;339(21):1485-92. doi: 10.1056/NEJM199811193392101.

  PMID: 9819446 BACKGROUND

• Poynard T, Marcellin P, Lee SS, Niederau C, Minuk GS, Ideo G, Bain V, Heathcote J, Zeuzem S, Trepo C, Albrecht J. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group (IHIT). Lancet. 1998 Oct 31;352(9138):1426-32. doi: 10.1016/s0140-6736(98)07124-4.

  PMID: 9807989 BACKGROUND

• Lindsay KL, Trepo C, Heintges T, Shiffman ML, Gordon SC, Hoefs JC, Schiff ER, Goodman ZD, Laughlin M, Yao R, Albrecht JK; Hepatitis Interventional Therapy Group. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology. 2001 Aug;34(2):395-403. doi: 10.1053/jhep.2001.26371.

  PMID: 11481625 BACKGROUND

• 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.

  PMID: 11583749 BACKGROUND

• Shiffman ML, Hofmann CM, Sterling RK, Luketic VA, Contos MJ, Sanyal AJ. A randomized, controlled trial to determine whether continued ribavirin monotherapy in hepatitis C virus-infected patients who responded to interferon-ribavirin combination therapy will enhance sustained virologic response. J Infect Dis. 2001 Aug 15;184(4):405-9. doi: 10.1086/322778. Epub 2001 Jul 16.

  PMID: 11471097 BACKGROUND

• 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.

  PMID: 12324553 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin; Epoetin Alfa

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mitchell L. Shiffman, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 3, 2005
• Study Start: May 1, 2002
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

US (1)