A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C

NCT01659567 | Completed Results FDA Drug

• 1 other identifier: ML25544
• Study Type: observational
• Target: 516
• Locations: 1 country
• Sites: 3

Brief Summary

This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Achieving Sustained Virological Response (SVR)

  SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep \[CAP\]/ COBAS TaqMan \[CTM\] test). Percentage of participants achieving SVR was reported.

  At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks

• Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR

  RVR was defined as HCV RNA less than or equal to (\<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

  At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

• PPV of Complete Early Viral Response (cEVR) on SVR

  cEVR was defined as HCV RNA \<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).

  At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks

Secondary Outcomes (11)

• Odds Ratio (OR) for Impact of Age on SVR

  Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

• OR for Impact of Gender on SVR

  Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

• OR for Impact of Body Weight on SVR

  Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

• OR for Impact of Baseline Level of Fibrosis (kPa) on SVR

  Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

• OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR

  Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)

Study Arms (1)

Chronic Hepatitis C

Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.

Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Interventions

Pegylated Interferon Alfa-2a DRUG

Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.

Also known as: Pegasys

Chronic Hepatitis C

Ribavirin DRUG

Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.

Also known as: Copegus

Chronic Hepatitis C

Eligibility Criteria

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

Study Population

Adult participants with chronic hepatitis C infection and naive to peginterferon/ribavirin treatment

You may qualify if:

• \- Diagnosis of chronic hepatitis C infection

You may not qualify if:

• Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B
• Participants previously treated with pegylated interferon alfa-2a/ribavirin
• Participation in another clinical study within 30 days prior to study start of ML25544

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Hepatology Clinic Hepa

Tbilisi, 0159, Georgia

Location

Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, 0160, Georgia

Location

Ltd Mrcheveli

Tbilisi, 0160, Georgia

Location

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-La Roche

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

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 8, 2012
• Study Start: April 6, 2011
• Primary Completion: October 20, 2015
• Study Completion: October 20, 2015
• Last Updated: October 3, 2017
• Results First Posted: October 3, 2017

Record last verified: 2017-05

Locations

GE (3)