NCT01750216

Brief Summary

This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.5 years

First QC Date

December 12, 2012

Last Update Submit

November 1, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1

    approximately 3 years

Secondary Outcomes (3)

  • Safety: Incidence of adverse events

    approximately 3 years

  • Sustained virological response (SVR) rate, in relation to early virological response (EVR) in different stages of liver fibrosis in treatment naïve patients with chronic hepatitis C genotype 1

    approximately 3 years

  • Response rates (RVR, EVR, SVR) according to host/virus/treatment-related factors in different stages of liver fibrosis (F>/=3 and </=3)

    approximately 3 years

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys and Copegus

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Chronic hepatitis C genotype 1
  • Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin
  • Confirmed serum positive HCV RNA
  • Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment

You may not qualify if:

  • Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus
  • Co-infection with hepatitis B or HIV
  • Post-transplant patients
  • End stage renal disease (creatinine clearance \< 15 ml/min)
  • Patients treated with immunotherapy
  • Pregnant women and male partners of women who are pregnant
  • Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Bydgoszcz, 85-030, Poland

Location

Unknown Facility

Bytom, 41-902, Poland

Location

Unknown Facility

Chorzów, 41-500, Poland

Location

Unknown Facility

Ciechanów, 06-400, Poland

Location

Unknown Facility

Dębica, 39-200, Poland

Location

Unknown Facility

Katowice, 40-752, Poland

Location

Unknown Facility

Koszalin, 75-581, Poland

Location

Unknown Facility

Lodz, 91-357, Poland

Location

Unknown Facility

Mielec, 39-300, Poland

Location

Unknown Facility

Puławy, 24-100, Poland

Location

Unknown Facility

Radom, 26-600, Poland

Location

Unknown Facility

Warsaw, 04-141, Poland

Location

Unknown Facility

Wałbrzych, 58-300, Poland

Location

Unknown Facility

Łańcut, 37-100, Poland

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

PL(14)