Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection

NCT01771653 | Completed

• 1 other identifier: KOI-SIUSOM-12-002
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to compare two approved treatment regimen(s) containing boceprevir and telaprevir, as part of standard of care for the treatment of hepatitis C.

Conditions

Hepatitis C Infection

Keywords

Hepatitis C infection; Hepatitis C Virus; HCV

Outcome Measures

Primary Outcomes (1)

• Virologic Response

  Sustained Virologic Response (SVR) rates will be compared between the two arms of treatment through measured HCV RNA levels after 24 weeks, 48 weeks and 96 weeks after completion of treatment.

  up to 96 weeks post treatment

Secondary Outcomes (2)

• Adverse events

  24, 48, and 96 weeks post treatment

• Effect of baseline variables on treatment outcome

  24, 48, and 96 weeks post treatment

Study Arms (2)

Previously treated

Data from patients who were previously treated with Peg, interferon (IFN), alfa, and ribavirin

Previously untreated

Records of patients who have never received anti-HCV treatment.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Population of adults aged 18-64 years, diagnosed with HCV genotype 1, with an HCV RNA \>100,000. They should have had a liver biopsy within 5 years before enrollment. Lab work to determine eligibility includes an absolute neutrophil count of at least 1200 per cubic millimeter, a platelet count of at least 90,000 per cubic millimeter and a hemoglobin level of at least 12 g per deciliter

You may qualify if:

• Age - 18-64 years
• HCV genotype 1
• HCV RNA \>100,000
• Liver biopsy within 5 years before enrollment
• Absolute neutrophil count of at least 1200 per cubic millimeter
• Platelet count of at least 90,000 per cubic millimeter
• Hemoglobin level of at least 12 g per deciliter
• Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) forms

You may not qualify if:

• HCV genotypes other than genotype 1
• Immunocompromised conditions including HIV, transplant or immunosuppressive drugs
• Decompensated liver disease or hepatocellular carcinoma
• Any other types of active cancer
• Active autoimmune disorders
• Major psychiatric disorders
• Active drug or alcohol use
• Pregnancy or lactation
• Patients with allergy to any of the drugs used in this study
• Drugs that may interact with boceprevir or telaprevir as listed in the package insert

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62701, United States

Location

Related Publications (10)

• Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.

  PMID: 11439948 BACKGROUND

• Di Bisceglie AM, Lyra AC, Schwartz M, Reddy RK, Martin P, Gores G, Lok AS, Hussain KB, Gish R, Van Thiel DH, Younossi Z, Tong M, Hassanein T, Balart L, Fleckenstein J, Flamm S, Blei A, Befeler AS; Liver Cancer Network. Hepatitis C-related hepatocellular carcinoma in the United States: influence of ethnic status. Am J Gastroenterol. 2003 Sep;98(9):2060-3. doi: 10.1111/j.1572-0241.2003.t01-1-07641.x.

  PMID: 14499788 BACKGROUND

• Witthoeft T, Hueppe D, John C, Goelz J, Heyne R, Moeller B, Teuber G, Wollschlaeger S, Baumgarten A, Simon KG, Moog G, Dikopoulos N, Mauss S. Efficacy and tolerability of peginterferon alfa-2a or alfa-2b plus ribavirin in the daily routine treatment of patients with chronic hepatitis C in Germany: the PRACTICE study. J Viral Hepat. 2010 Jul;17(7):459-68. doi: 10.1111/j.1365-2893.2009.01255.x. Epub 2010 Feb 11.

  PMID: 20158603 BACKGROUND

• O'Brien TR, Everhart JE, Morgan TR, Lok AS, Chung RT, Shao Y, Shiffman ML, Dotrang M, Sninsky JJ, Bonkovsky HL, Pfeiffer RM; HALT-C Trial Group. An IL28B genotype-based clinical prediction model for treatment of chronic hepatitis C. PLoS One. 2011;6(7):e20904. doi: 10.1371/journal.pone.0020904. Epub 2011 Jul 8.

  PMID: 21760886 BACKGROUND

• Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.

  PMID: 21449783 BACKGROUND

• Koirala J, Gandotra SD, Rao S, Sangwan G, Mushtaq A, Htwe TH, Adamski A, Blessman D, Khardori NM. Granulocyte colony-stimulating factor dosing in pegylated interferon alpha-induced neutropenia and its impact on outcome of anti-HCV therapy. J Viral Hepat. 2007 Nov;14(11):782-7. doi: 10.1111/j.1365-2893.2007.00870.x.

  PMID: 17927614 BACKGROUND

• Bacon BR, Gordon SC, Lawitz E, Marcellin P, Vierling JM, Zeuzem S, Poordad F, Goodman ZD, Sings HL, Boparai N, Burroughs M, Brass CA, Albrecht JK, Esteban R; HCV RESPOND-2 Investigators. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1207-17. doi: 10.1056/NEJMoa1009482.

  PMID: 21449784 BACKGROUND

• Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.

  PMID: 21696307 BACKGROUND

• Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.

  PMID: 21696308 BACKGROUND

• McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303. doi: 10.1056/NEJMoa0908014.

  PMID: 20375406 BACKGROUND

Related Links

• telaprevir prescribing information

MeSH Terms

Conditions

Hepatitis C

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

Study Officials

• Janak Koirala, MD, MPH

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 18, 2013
• Study Start: September 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

US (1)