NCT00905632

Brief Summary

The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for phase_1

Geographic Reach
3 countries

18 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

May 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

April 19, 2016

Completed
Last Updated

April 19, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

May 19, 2009

Results QC Date

January 21, 2016

Last Update Submit

March 17, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir.

    The primary efficacy endpoint is the number of participants with virologic response defined as \>= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as \>= 1 log increase in viral load from nadir.

    Baseline and 4 weeks

Secondary Outcomes (20)

  • Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline

    Baseline and days 1, 2, 4, 8, 15, 22 and 28

  • Viral Load at Each Visit up to Day 28

    Baseline and days 8, 15, 22 and 28

  • Number of Participants With Virologic Response at Day 28

    day 28

  • Number of Participants With Rapid Virological Response

    4 weeks

  • Number of Participants With Early Virological Response

    Baseline and week 12

  • +15 more secondary outcomes

Study Arms (4)

BI 207127 low dose + SOC

EXPERIMENTAL

BI 207127 low dose tid + SOC

Drug: BI 207127 low dose + SOC

BI 207127 middle dose +SOC

EXPERIMENTAL

BI 207127 middle dose tid + SOC

Drug: BI 207127 middle dose +SOC

BI 207127 high dose+SOC

EXPERIMENTAL

BI 207127 high dose tid +SOC

Drug: BI 207127 high dose+SOC

Placebo + SOC

PLACEBO COMPARATOR

Placebo tid +SOC

Drug: Placebo + SOC

Interventions

BI 207127 middle dose +SOCDRUG

BI 207127 middle dose tid + SOC

BI 207127 middle dose +SOC
BI 207127 high dose+SOCDRUG

BI 207127 high dose tid +SOC

BI 207127 high dose+SOC
Placebo + SOCDRUG

Placebo tid +SOC

Placebo + SOC
BI 207127 low dose + SOCDRUG

BI 207127 low dose tid + SOC

BI 207127 low dose + SOC

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HCV genotype 1
  • HCV viral load \>100,000 IU/mL
  • histology or fibroscan to rule out cirrhosis
  • Absence of retinopathy
  • treatment naive patients and treatment experienced patients
  • Age 18 - 70 years
  • Male OR female with documented hysterectomy OR postmenopausal

You may not qualify if:

  • Fertile males not willing to use an adequate form of contraception
  • Pretreatment with any HCV-polymerase inhibitor
  • Any concurrent disease if clinically significant based on the investigator's medical assessment
  • Current alcohol or drug abuse, or history of the same
  • Positive test for HIV or HBs
  • History of malignancy
  • Planned or concurrent usage of any other pharmacological therapy including any antiviral therapy or vaccination
  • Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer
  • Any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
  • Patients treated with any interferon (approved or investigational) or Peg-IFN and/or Ribavirin within 3 months prior to screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

1241.7.3307A CHU de Grenoble

Grenoble Cédex 9, France

Location

1241.7.3303A Hôpital Claude Huriez

Lille, France

Location

1241.7.3302A Hopital de l'Hotel Dieu

Lyon, France

Location

1241.7.3301A Hôpital Saint Eloi

Montpellier, France

Location

1241.7.3305A HOP Archet 2

Nice, France

Location

1241.7.3306A Hôpital Haut-Lévêque

Pessac, France

Location

1241.7.3304A HOP de Brabois

Vandœuvre-lès-Nancy, France

Location

1241.7.49010 Boehringer Ingelheim Investigational Site

Aachen, Germany

Location

1241.7.49012 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1241.7.49004 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1241.7.49011 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, Germany

Location

1241.7.49001 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1241.7.49013 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1241.7.49009 Boehringer Ingelheim Investigational Site

Regensburg, Germany

Location

1241.7.49002 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

1241.7.41003 Boehringer Ingelheim Investigational Site

Basel, Switzerland

Location

1241.7.41004 Boehringer Ingelheim Investigational Site

Lugano, Switzerland

Location

1241.7.41001 Boehringer Ingelheim Investigational Site

Sankt Gallen, Switzerland

Location

Related Publications (1)

  • Larrey D, Lohse AW, de Ledinghen V, Trepo C, Gerlach T, Zarski JP, Tran A, Mathurin P, Thimme R, Arasteh K, Trautwein C, Cerny A, Dikopoulos N, Schuchmann M, Heim MH, Gerken G, Stern JO, Wu K, Abdallah N, Girlich B, Scherer J, Berger F, Marquis M, Kukolj G, Bocher W, Steffgen J. Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin. J Hepatol. 2012 Jul;57(1):39-46. doi: 10.1016/j.jhep.2012.02.015. Epub 2012 Mar 10.

    PMID: 22414766DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

deleobuvir

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

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2011

Last Updated

April 19, 2016

Results First Posted

April 19, 2016

Record last verified: 2016-03

Locations

CH(3)FR(7)DE(8)