A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

NCT00922779 | Completed Phase 4 Results

• 1 other identifier: ML16709
• Study Type: interventional
• Target: 6,661
• Locations: 1 country
• Sites: 93

Brief Summary

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.

  From signing of informed consent up to end of study (up to Week 72)

Secondary Outcomes (3)

• Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy

  24 weeks after end of therapy (Week 72)

• Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation

  Weeks 12,24 and 48 After Therapy Initiation

• Percentage of Participants With Change in Hemoglobin Level

  Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)

Study Arms (1)

1

EXPERIMENTAL

Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin

Interventions

peginterferon alfa-2a [Pegasys] DRUG

180micrograms sc weekly for 12-48 weeks

1

ribavirin DRUG

800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

1

Eligibility Criteria

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

You may qualify if:

• adult patients, \>=18 years of age;
• serological evidence of chronic hepatitis C;
• detectable serum HCV-RNA;
• liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

You may not qualify if:

• history or other evidence of a medical condition associated with chronic liver disease other than HCV;
• co-infection with active hepatitis A or B;
• hepatocellular carcinoma;
• patients with severe cardiovascular disease whose condition may worsen due to acute anemia.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (93)

Unknown Facility

Arkhangelsk, 163000, Russia

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Barnaul, 656010, Russia

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Barnaul, 656045, Russia

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Blagoveshchensk, 675007, Russia

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Cheboksary, 428016, Russia

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Chelyabinsk, 454048, Russia

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Chelyabinsk, 454052, Russia

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Chelyabinsk, 454071, Russia

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Cherepovets, 162600, Russia

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Chita, 672090, Russia

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Irkutsk, 664043, Russia

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Irkutsk, 664047, Russia

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Irkutsk, 664079, Russia

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Izhevsk, 426067, Russia

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Kazan', 420097, Russia

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Kemerovo, 650000, Russia

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Kemerovo, 650036, Russia

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Kemerovo, 650099, Russia

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Khabarovsk, 680009, Russia

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Khabarovsk, 680022, Russia

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Khabarovsk, 680031, Russia

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Kirov, 610000, Russia

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Krasnodar, 350012, Russia

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Krasnodar, 350015, Russia

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Krasnodar, 350086, Russia

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Krasnoyarsk, 660022, Russia

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Krasnoyarsk, 660049, Russia

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Lipetsk, 398043, Russia

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Makhachkala, 367008, Russia

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Moscow, 103875, Russia

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Moscow, 105203, Russia

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Moscow, 109325, Russia

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Moscow, 111020, Russia

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Moscow, 111123, Russia

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Moscow, 115201, Russia

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Moscow, 115446, Russia

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Moscow, 115516, Russia

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Moscow, 115682, Russia

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Moscow, 119002, Russia

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Moscow, 119881, Russia

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Moscow, 121293, Russia

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Moscow, 123098, Russia

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Moscow, 123367, Russia

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Moscow, 125101, Russia

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Moscow, 125367, Russia

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Moscow, 127247, Russia

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Moscow, 129110, Russia

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Moscow, 143420, Russia

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Moscow, Russia

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Nizhny Novgorod, 603022, Russia

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Novokuznetsk, 654018, Russia

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Novokuznetsk, 654029, Russia

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Novosibirsk, 630016, Russia

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Novoural'sk, 624130, Russia

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Omsk, 644010, Russia

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Orenburg, 460035, Russia

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Petropavlovsk-Kamchatskiy, 683003, Russia

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Rostov-on-Don, 344022, Russia

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Saint Petersburg, 191167, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 195275, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 198103, Russia

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Saint Petersburg, 199034, Russia

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Salekhard, 629001, Russia

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Samara, 443011, Russia

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Samara, 443021, Russia

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Saratov, 410026, Russia

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Saratov, 410028, Russia

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Saratov, 410040, Russia

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Sashi, 354057, Russia

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Stavropol, 355017, Russia

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Surgut, 628400, Russia

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Tomsk, 634050, Russia

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Tyumen, 625002, Russia

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Tyumen, 625017, Russia

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Tyumen, 625026, Russia

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Tyumen, 629806, Russia

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Ufa, 450000, Russia

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Ufa, 450005, Russia

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Ulan-Ude, 670042, Russia

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Vladivostok, 690011, Russia

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Vladivostok, 690065, Russia

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Volgograd, 400040, Russia

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Volgograd, 400138, Russia

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Yakutsk, 677000, Russia

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Yekaterinburg, 620020, Russia

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Yekaterinburg, 620042, Russia

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Yekaterinburg, 620102, Russia

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Yujno-sakhalinsk, 690000, Russia

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Yujno-sakhalinsk, 693000, Russia

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MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2a; 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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: June 1, 2002
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 20, 2016
• Results First Posted: January 20, 2016

Record last verified: 2015-12

Locations

RU (93)