Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients

NCT00803309 | Terminated Phase 4 DMC

• 1 other identifier: P05498
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 49

Brief Summary

In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin. The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who are not HCV-RNA negative (\< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment.

Conditions

Hepatitis C, Chronic

Keywords

Chronic HCV-genotype 2/3; Efficacy of treatment extension; PegIntron; pegylated interferon alpha-2b; Rebetol; ribavirin

Outcome Measures

Primary Outcomes (1)

• Reduction of Relapse rate (HCV-RNA positive in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) 24 weeks after the end of treatment and thus improvement of sustained virological response rates (SVR)

  48 weeks (arm A) or 36 weeks (arm B)

Secondary Outcomes (4)

• Virological response rates (HCV-RNA negative in serum by a standard HCV-PCR with a detection limit of at least 15 IU/ml) at the end of therapy

  24 weeks (arm A) or 12 weeks (arm B)

• Biochemical responses as determined by ALT and AST levels at the end of treatment and at the end of follow up.

  Arm A: 24 and 24 weeks, arm B: 12 and 24 weeks

• Severity and frequency of adverse event

  48 weeks (arm A) or 36 weeks (arm B)

• Analysis of quality of life

  48 weeks (arm A) or 36 weeks (arm B)

Study Arms (2)

A

ACTIVE COMPARATOR

PegIntron® 1.5 µg/kg once weekly (QW) subcutaneous (sc) plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 24 weeks beyond standard treatment with 24 weeks follow-up

Drug: pegylated interferon alpha-2b; Drug: Ribavirin

B

ACTIVE COMPARATOR

PegIntron® 1.5 µg/kg QW sc plus Rebetol® 800-1400 mg per os divided in 2 daily doses for additional 12 weeks beyond standard treatment with 24 weeks follow-up

Drug: pegylated Interferon alpha-2b; Drug: Ribavirin

Interventions

pegylated Interferon alpha-2b DRUG

1.5 µg/kg once weekly, syringe, 24 weeks

Also known as: PegIntron

A

Ribavirin DRUG

800-1400 mg per os, daily, tablets, 24 weeks

Also known as: Rebetol

A

Eligibility Criteria

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

You may qualify if:

• Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (\> 15 IU/mL) and positivity of anti-HCV antibodies
• Age ≥ 18 years
• Compensated liver disease (Child-Pugh Grade A clinical classification)
• Negative urine or blood pregnancy test (one of the both; for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
• Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron®) and \> 10.6 mg/kg ribavirin (Rebetol®)
• No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
• Willingness to give written informed consent and willingness to participate to and to comply with the study protocol

You may not qualify if:

• Women with ongoing pregnancy or breast feeding
• Male partners of women who are pregnant
• Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
• History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
• History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
• Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
• Absolute neutrophil count (ANC) \<750 cells/mm3 at screening
• Platelet count \<50,000 cells/mm3 at screening
• Hb \<10 g/dl at screening
• Dose modification of Peg-Interferon alpha-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy
• Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
• Less than 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
• Serum creatinine level \>1.5 times the upper limit of normal at screening
• History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
• History of a severe seizure disorder or current anticonvulsant use

Sponsors & Collaborators

• HepNet Study House, German Liverfoundation: lead
• Hannover Medical School: collaborator

Study Sites (49)

Ärztehaus Leipziger Straße

Berlin, 10117, Germany

Location

Medizinisches Infektiologiezentrum

Berlin, 10439, Germany

Location

Praxis Dr. med. Naumann

Berlin, 10627, Germany

Location

Hepatologische Schwerpunktpraxis im bng

Berlin, 10969, Germany

Location

Charité Campus Virchow-Klinikum, Med. Klinik für Gastroenterologie und Hepatologie

Berlin, 13353, Germany

Location

Praxis Dr. med. J. Gölz

Berlin, 14057, Germany

Location

Praxis Meyer

Berlin, 14057, Germany

Location

Friedrich-Wilhelms-Universität, Med. Klinik und Poliklinik I

Bonn, 53105, Germany

Location

Klinikum Bremen-Mitte gGmbH

Bremen, 28205, Germany

Location

Kreiskliniken Burghausen/Altötting, Med. Klinik II

Burghausen/Altötting, 84489, Germany

Location

Hepatologische Schwerpunktpraxis im bng

Dortmund, 44263, Germany

Location

Krankenhaus Dresden-Friedrichstadt

Dresden, 01067, Germany

Location

Fachärztliche Gemeinschaftspraxis

Düsseldorf, 40223, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Klinikum der J.W. Goethe-Universität

Frankfurt, 60590, Germany

Location

Vitanus GmbH

Frankfurt, 60596, Germany

Location

Praxis Zentrum Gastroenterologie und Endokrinologie

Freiburg im Breisgau, 79098, Germany

Location

Asklepios Klinik St. Georg, Institut für interdiziplinäre Infektiologie

Hamburg, 20099, Germany

Location

IPM-Studycenter GmbH & Co. KG

Hamburg, 20099, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Klinik für Innere Medizin

Hamburg, 20246, Germany

Location

Universtätsklinikum Hamburg-Eppendorf;Innere Medizin

Hamburg, 20246, Germany

Location

Praxis Dr. med. S. Holm

Hanover, 30159, Germany

Location

Leberpraxis Hannover

Hanover, 30161, Germany

Location

Medizinische Hochschule Hannover, Zentrum Innere Medizin

Hanover, 30625, Germany

Location

Medizinische Fakultät der Universität Heidelberg, Innere Medizin IV

Heidelberg, 69120, Germany

Location

Hepatologische Schwerpunktpraxis im bng

Herne, 44623, Germany

Location

Universitätskliniken des Saarlandes, Innere Medizin II, Gastroenterologie

Homburg, 66424, Germany

Location

Klinik für Innere Medizin der FSU

Jena, 07747, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Allgemeine Innere Medizin

Kiel, 24105, Germany

Location

Gastroenterologische Gemeinschaftspraxis

Kiel, 24146, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Gemeinschaftspraxis Dr.Simon

Leverkusen, 51375, Germany

Location

Universitätklinikum Schleswig-Holstein, Campus Lübeck, Med. Klinik I

Lübeck, 23538, Germany

Location

Otto-von-Guericke Universität Magdeburg

Magdeburg, 39120, Germany

Location

Klinikum der Johannes Gutenberg Universität Med. Klinik

Mainz, 55131, Germany

Location

Universitäts-Klinikum Mannheim, Med. Klinik II

Mannheim, 68167, Germany

Location

Hepatologische Schwerpunktpraxis im bng

Minden, 32423, Germany

Location

Klinikum Großhadern, Med. Klinik 2

München, 81366, Germany

Location

Universitätsklinikum Münster, Med. Klinik und Poliklinik B

Münster, 48149, Germany

Location

St.-Theresien-Krankenhaus

Nuremberg, 90491, Germany

Location

St. Josef Hospital

Oberhausen, 46045, Germany

Location

Hepatologische Schwerpunktpraxis im bng

Offenbach, 63065, Germany

Location

St.-Josefs-Klinik, Med. Klinik

Offenburg, 77654, Germany

Location

Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin I

Regensburg, 93053, Germany

Location

Diakoniekrankenhaus, Med. Klinik II

Rotenburg (Wümme), 27356, Germany

Location

Praxis Dr. med. A. Trein

Stuttgart, 70197, Germany

Location

Universitätsklinikum Tübingen Medizinische Klinik I

Tübingen, 70206, Germany

Location

Universitätsklinikum Ulm, Abteilung für Innere Medizin I

Ulm, 89081, Germany

Location

Med. Poliklinik der Universität Würzburg

Würzburg, 97080, Germany

Location

Related Publications (1)

• Heidrich B, Cordes HJ, Klinker H, Moller B, Naumann U, Rossle M, Kraus MR, Boker KH, Roggel C, Schuchmann M, Stoehr A, Trein A, Hardtke S, Gonnermann A, Koch A, Wedemeyer H, Manns MP, Cornberg M. Treatment Extension of Pegylated Interferon Alpha and Ribavirin Does Not Improve SVR in Patients with Genotypes 2/3 without Rapid Virological Response (OPTEX Trial): A Prospective, Randomized, Two-Arm, Multicentre Phase IV Clinical Trial. PLoS One. 2015 Jun 9;10(6):e0128069. doi: 10.1371/journal.pone.0128069. eCollection 2015.

  PMID: 26057627 RESULT

Related Links

• The network of competence for hepatitis (Hep-Net) will support the nation-wide research of viral hepatitis and will develop uniform diagnostic and therapeutic standards for five years.

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; 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

• Michael P. Manns, Prof. Dr.

  Hannover Medical School

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

DE (49)