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

Hepatitis C Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771653
• Other study ID #: KOI-SIUSOM-12-002
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: January 15, 2016
• Start date: September 2011
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Southern Illinois University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

The objective of the study is to compare the effect of adding 2 oral hepatitis C virus (HCV) protease inhibitors, telaprevir versus boceprevir, as part of current standard treatment regimen with (pegylated-interferon-alpha + ribavirin) for HCV Genotype-1 infection. Data will be obtained from medical records of consenting patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Locations

Country	Name	City	State
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Southern Illinois University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. Review. — View Citation

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. Erratum in: N Engl J Med. 2010 Apr 29;362(17):1647. Dosage error in article text. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Müllhaupt 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events	Comparison of rates and severity of adverse events between the two study arms	24, 48, and 96 weeks post treatment	Yes
Secondary	Effect of baseline variables on treatment outcome	Analyze the effects of baseline variables on treatment outcome between the two groups- age, race, social economic status.	24, 48, and 96 weeks post treatment	No

External Links

•   Link
•   telaprevir prescribing information