A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
This study is ongoing, but not recruiting participants.
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01225380
First received: October 18, 2010
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C Infection |
Drug: GS-9190 Drug: GS-9256 Biological: Pegasys® Drug: Copegus® Drug: GS-9190 placebo Drug: GS-9256 placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123) |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Sustained virologic response (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation [ Time Frame: 24 weeks of off-treatment follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events [ Time Frame: Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-up ] [ Designated as safety issue: Yes ]
- Emergence of viral resistance following initiation of therapy with GS-9190 and GS-9256 [ Time Frame: Through up to 48 weeks treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry Substudy ] [ Designated as safety issue: No ]
- Viral dynamics and steady state pharmacokinetics of GS-9190 and GS-9256 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9256 over time [ Time Frame: Through Week 4 of therapy ] [ Designated as safety issue: No ]
- Long-term assessment of plasma HCV RNA in subjects who achieve SVR [ Time Frame: 36 months following Week 72 ] [ Designated as safety issue: No ]Plasma HCV RNA will be measured at approximately 6, 12, 24, and 36 months after Week 72.
| Estimated Enrollment: | 320 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | January 2017 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
GS-9190 and GS-9256 in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy
|
Drug: GS-9190
GS-9190 capsule, 20 mg BID, 16 or 24 weeks
Drug: GS-9256
GS-9256 capsule, 150 mg BID, 16 or 24 weeks
Biological: Pegasys®
peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
|
|
Experimental: Arm 2
GS-9256 (active) and placebo matching GS-9190 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy
|
Drug: GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
Drug: GS-9256
GS-9256 capsule, 150 mg BID, 24 weeks
Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
|
|
Placebo Comparator: Arm 3
Placebo matching GS-9190 and placebo matching GS-9256 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration
|
Drug: GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
Drug: GS-9256 placebo
placebo matching GS-9256 capsule BID, 24 weeks
Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
Drug: Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult subjects 18 to 70 years of age
- Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
- Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
- Monoinfection with HCV genotype 1a or 1b
- HCV treatment-naïve
- Body mass index (BMI) between 18 and 36 kg/m2
- Creatinine clearance >/= 50 mL/min
- Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
- Screening laboratory values within defined thresholds for ALT, AST, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium
Exclusion Criteria:
- Autoimmune disease
- Decompensated liver disease or cirrhosis
- Poorly controlled diabetes mellitus
- Severe psychiatric illness
- Severe chronic obstructive pulmonary disease (COPD)
- Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
- History of hemoglobinopathy
- Known retinal disease
- Subjects who are immunosuppressed
- Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
- Subjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
- Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225380
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| United States, Arizona | |
| Mayo Clinic | |
| Phoenix, Arizona, United States, 85054 | |
| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| Scripps Clinic | |
| La Jolla, California, United States, 92037 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Medical Associates Research Group | |
| San Diego, California, United States, 92123 | |
| Kaiser Permanente | |
| San Diego, California, United States, 92154 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| South Denver Gastroenterology | |
| Englewood, Colorado, United States, 80110 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| University of Miami Center for Liver Diseases | |
| Miami, Florida, United States, 33136 | |
| Orlando Immunology Center | |
| Orlando, Florida, United States, 32803 | |
| Bach and Godofsky Infectious Diseases | |
| Sarasota, Florida, United States, 34243 | |
| United States, Georgia | |
| Atlanta Gastroenterology Associates | |
| Atlanta, Georgia, United States, 30308 | |
| Emory University, Infectious Disease Clinic | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Gastroenterology Associates, LLC | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Lutherville, Maryland, United States, 21093 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
| United States, New Mexico | |
| Southwest CARE Center | |
| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
| North Shore University Hospital | |
| Great Neck, New York, United States, 11021 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| Cornell University Gastroenterology & Hepatology | |
| New York, New York, United States, 10021 | |
| Concorde Medical Group | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| University Gastroenterology | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| Memphis Gastroenterology Group | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Texas | |
| The North Texas Research Institute | |
| Arlington, Texas, United States, 76012 | |
| UT Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 39090 | |
| Alamo Medical Research | |
| San Antonio, Texas, United States, 78215 | |
| United States, Virginia | |
| Metropolitan Research | |
| Fairfax, Virginia, United States, 22031 | |
| Liver Institute of Virginia, Bon Secours | |
| Newport News, Virginia, United States, 23602 | |
| Digestive and Liver Disease Specialists | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Virginia Mason Medical Center, Digestive Disease Institute | |
| Seattle, Washington, United States, 98101 | |
| Austria | |
| Medizinische Universität Graz | |
| Graz, Austria, 8036 | |
| LKH Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Krankenhaus der Elisabethinen Linz GmbH | |
| Linz, Austria, 4020 | |
| AKH der Stadt Wien | |
| Vienna, Austria, 1090 | |
| Wilhelminenspital der Stadt Wien | |
| Vienna, Austria, 1171 | |
| Belgium | |
| SGS - Clinical Pharmacology Unit Antwerpen | |
| Antwerpen, Belgium, 2060 | |
| ULB Erasme | |
| Brussels, Belgium, 1070 | |
| UCL Saint Luc | |
| Brussels, Belgium, 1200 | |
| UZ Antwerp | |
| Edegem, Belgium, 2650 | |
| CHU Sart Tilman | |
| Liege, Belgium, 4000 | |
| Canada, Alberta | |
| Heritage Medical Research Clinic | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| University of Alberta, Division of Gastroenterology | |
| Edmonton, Alberta, Canada, T6G 2C2 | |
| Canada, British Columbia | |
| Downtown ID Clinic | |
| Vancouver, British Columbia, Canada, V3S 4N9 | |
| GI Research Institute | |
| Vancouver, British Columbia, Canada, V6Z 2K5 | |
| Gordon & Leslie Diamond Health Care Centre | |
| Vancouver, British Columbia, Canada, V5Z 3P1 | |
| Canada, Manitoba | |
| John Buhler Research Centre | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, Ontario | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 5A5 | |
| Ottawa Hospital, Division of Infectious Diseases | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Czech Republic | |
| University Hospital Brno | |
| Brno, Czech Republic, 625 00 | |
| Melnik Hospital | |
| Melnik, Czech Republic, 276 01 | |
| University Hospital Plzen | |
| Plzen, Czech Republic, 304 60 | |
| Klinmed, s.r.o. | |
| Prague, Czech Republic, 128 00 | |
| Institute of Clinic and Experimental Medicine | |
| Prague, Czech Republic, 140 21 | |
| Association of Physicians for Infection Diseases | |
| Usti Nad labem, Czech Republic, 477 01 | |
| France | |
| Beaujon Hospital | |
| Clichy, France, 92110 | |
| Henri Mondor Hospital | |
| Créteil, France, 94000 | |
| Claude Huriez Hospital | |
| Lille, France, 59000 | |
| Hotel Dieu Hospital | |
| Lyon, France, 69002 | |
| Saint Joseph Hospital | |
| Marseille, France, 13008 | |
| Nancy University Hospital Center | |
| Vandoeuvre, France, 54500 | |
| Germany | |
| Charite University Medicine | |
| Berlin, Germany, 13353 | |
| University Hospital Bonn | |
| Bonn, Germany, 53105 | |
| University Hospital Essen | |
| Essen, Germany, 45122 | |
| Klinikum der Johann Wolfgang Goethe-Universität | |
| Frankfurt/M, Germany, 60590 | |
| University Hospital Freiburg | |
| Freiburg, Germany, 79106 | |
| Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH | |
| Hamburg, Germany, 20099 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, 30625 | |
| University hospital Heidelberg | |
| Heidelberg, Germany, 69120 | |
| University Hospital Leipzig | |
| Leipzig, Germany, 04103 | |
| Johannes Gutenberg University Hospital | |
| Mainz, Germany, 55131 | |
| Ludwig-Maximilians-University Munich | |
| München, Germany, 81377 | |
| Italy | |
| Epatologia, Azienda Ospedaliero "Spedali Civili" | |
| Brescia, Italy, 25123 | |
| U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | |
| Milano, Italy, 20122 | |
| Medicina Generale - Azienda Ospedaliera di Padova | |
| Padova, Italy, 35128 | |
| U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone | |
| Palermo, Italy, 90127 | |
| Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria | |
| Parma, Italy, 43100 | |
| Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista | |
| Torino, Italy, 10126 | |
| Poland | |
| Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny | |
| Bialystok, Poland, 15-540 | |
| Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny | |
| Bydgoszcz, Poland, 85-030 | |
| Szpital Specjalistyczny w Chorzowie | |
| Chorzow, Poland, 41-500 | |
| Niepubliczny Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia | |
| Czeladz, Poland, 41-250 | |
| Wojewodzki Szpital Zespolony w Kielcach | |
| Kielce, Poland, 25-736 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie | |
| Krakow, Poland, 31-501 | |
| Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi | |
| Lodz, Poland, 91-347 | |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie | |
| Lublin, Poland, 20-081 | |
| Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby | |
| Radom, Poland, 26-610 | |
| Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie | |
| Szczecin, Poland, 71-455 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny | |
| Warszawa, Poland, 01-201 | |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie | |
| Warszawa, Poland, 02-507 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X | |
| Warszawa, Poland, 01-201 | |
| EMC Instytut Medyczny S.A. | |
| Wroclaw, Poland, 50-220 | |
| Spain | |
| Hospital Universitari Vall d'Hebrón | |
| Barcelona, Spain, 08035 | |
| Hospital Clínico Universitario San Cecilio | |
| Granada, Spain, 18012 | |
| Hospital Universitario Puerta de Hierro Majadahonda | |
| Madrid, Spain, 28222 | |
| Hospital Universitario Ramón y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital Universitario Ntra. Sra. de Valme | |
| Sevilla, Spain, 41014 | |
| Hospital General Universitario de Valencia | |
| Valencia, Spain, 46014 | |
| United Kingdom | |
| Queen Elizabeth Hospital | |
| Birmingham, United Kingdom, B15 2TH | |
| North Manchester General Hospital | |
| Greater Manchester, United Kingdom, M8 5RB | |
| Royal Liverpool University Hospital | |
| Liverpool, United Kingdom, L7 8XP UK | |
| University College London Hospital | |
| London, United Kingdom, NW1 2BU | |
| Kings College Hospital | |
| London, United Kingdom, SE5 9RS | |
| Chelsea and Westminster Hospital | |
| London, United Kingdom, SW109NH | |
| Barts and The London Hospital | |
| London, United Kingdom, E1 2AT | |
| Institute of Cellular Medicine (Hepatology) | |
| Newcastle Upon Tyne, United Kingdom, NE24HH | |
| Derriford Hospital | |
| Plymouth, United Kingdom, PL6 8DH | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Bittoo Kanwar | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01225380 History of Changes |
| Other Study ID Numbers: | GS-US-196-0123 |
| Study First Received: | October 18, 2010 |
| Last Updated: | March 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
Hepatitis C HCV Rapid Virologic Response Sustained Virologic Response Direct Acting Antiviral Combination Therapy |
HCV RNA Polymerase inhibitor Protease inhibitor Treatment naïve GS-9190 GS-9256 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Ribavirin Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013