NCT02556307

Brief Summary

In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

4 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

March 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 15, 2016

Completed
Last Updated

February 15, 2016

Status Verified

January 1, 2016

Enrollment Period

5.3 years

First QC Date

September 21, 2015

Results QC Date

January 18, 2016

Last Update Submit

January 18, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment

    SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (\<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).

    6 months after the last study drug administration (up to 123.6 weeks)

Secondary Outcomes (6)

  • Percentage of Participants With Undetectable HCV RNA

    Weeks 4, 12 and at end of treatment (up to 99.6 weeks)

  • HCV RNA Values

    Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

  • Thrombocyte Values

    Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

  • Leukocyte Values

    Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

  • Hemoglobin Values

    Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

  • +1 more secondary outcomes

Study Arms (1)

Peginterferon alfa-2a + Ribavirin

Drug: Peginterferon alfa-2aDrug: Ribavirin

Interventions

Peginterferon alfa-2aDRUG

Peginterferon alfa-2a according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Also known as: Pegasys
Peginterferon alfa-2a + Ribavirin
RibavirinDRUG

Ribavirin according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Also known as: Copegus
Peginterferon alfa-2a + Ribavirin

Eligibility Criteria

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

Slovenian patients with chronic hepatitis C (CHC) treated with Peginterferon alfa-2a and ribavirin.

You may qualify if:

  • Male and female patients \>/= 18 years
  • Positive test for HCV
  • Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

You may not qualify if:

  • Concomitant infection with HIV or hepatitis B
  • Participation in a clinical trial within 30 days prior to study start
  • Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Celje, 3000, Slovenia

Location

Unknown Facility

Ljubljana, 1000, Slovenia

Location

Unknown Facility

Maribor, 2000, Slovenia

Location

Unknown Facility

Novo Mesto, 8000, Slovenia

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

peginterferon alfa-2aRibavirin

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

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic 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
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 22, 2015

Study Start

March 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 15, 2016

Results First Posted

February 15, 2016

Record last verified: 2016-01

Locations

SL(4)