Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01358864 |
Recruitment Status
:
Completed
First Posted
: May 24, 2011
Results First Posted
: October 28, 2015
Last Update Posted
: August 29, 2016
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition: |
Hepatitis C, Chronic |
Interventions: |
Drug: BI 201335 Drug: Pegylated Interferon-alpha (IFN) Drug: Ribavirin (RBV) Drug: Placebo |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Reporting Groups
Description | |
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Relapser:Placebo | Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. |
Relapser:Faldaprevir 12 Weeks | Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. |
Relapser:Faldaprevir 24 Weeks | Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. |
Partial:Placebo | Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. |
Partial:Faldaprevir 12 Weeks | Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. |
Partial:Faldaprevir 24 Weeks | Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. |
Null:Faldaprevir 12 Weeks | Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. |
Null:Faldaprevir 24 Weeks | Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. |
Participant Flow: Overall Study
Relapser:Placebo | Relapser:Faldaprevir 12 Weeks | Relapser:Faldaprevir 24 Weeks | Partial:Placebo | Partial:Faldaprevir 12 Weeks | Partial:Faldaprevir 24 Weeks | Null:Faldaprevir 12 Weeks | Null:Faldaprevir 24 Weeks | |
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STARTED | 49 | 99 | 103 | 29 | 57 | 55 | 146 | 140 |
COMPLETED | 18 | 86 | 87 | 10 | 46 | 42 | 81 | 85 |
NOT COMPLETED | 31 | 13 | 16 | 19 | 11 | 13 | 65 | 55 |
Adverse Event | 0 | 6 | 9 | 0 | 4 | 8 | 12 | 7 |
Lack of Efficacy | 26 | 3 | 4 | 19 | 7 | 4 | 49 | 44 |
Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
Withdrawal by Subject | 3 | 4 | 2 | 0 | 0 | 1 | 1 | 3 |
Other reason not defined above | 2 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
Not treated | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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Full Analysis Set (FAS) |
Reporting Groups
Description | |
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Relapser:Placebo | Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. |
Relapser:Faldaprevir 12 Weeks | Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. |
Relapser:Faldaprevir 24 Weeks | Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone. |
Partial:Placebo | Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks. |
Partial:Faldaprevir 12 Weeks | Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. |
Partial:Faldaprevir 24 Weeks | Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. |
Null:Faldaprevir 12 Weeks | Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks. |
Null:Faldaprevir 24 Weeks | Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks. |
Total | Total of all reporting groups |
Baseline Measures
Relapser:Placebo | Relapser:Faldaprevir 12 Weeks | Relapser:Faldaprevir 24 Weeks | Partial:Placebo | Partial:Faldaprevir 12 Weeks | Partial:Faldaprevir 24 Weeks | Null:Faldaprevir 12 Weeks | Null:Faldaprevir 24 Weeks | Total | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [Units: Participants] |
49 | 99 | 103 | 29 | 57 | 55 | 145 | 140 | 677 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Age [Units: Years] Mean (Standard Deviation) |
53.4 (8.29) | 53.5 (8.57) | 53.7 (8.14) | 55.7 (7.50) | 52.7 (7.90) | 52.0 (10.32) | 53.2 (8.76) | 53.6 (8.13) | 53.4 (8.48) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Gender [Units: Participants] |
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Female | 20 | 44 | 43 | 10 | 20 | 20 | 54 | 63 | 274 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Male | 29 | 55 | 60 | 19 | 37 | 35 | 91 | 77 | 403 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

1. Primary: | Sustained Virological Response 12 Weeks Post Treatment (SVR12) [ Time Frame: 12 weeks post treatment, up to 60 weeks ] |
2. Secondary: | Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) [ Time Frame: 24 weeks post treatment, up to 72 weeks ] |
3. Secondary: | Early Treatment Success (ETS) [ Time Frame: Week 4 and Week 8 ] |
4. Secondary: | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO [ Time Frame: End of treatment, up to 48 weeks ] |
5. Secondary: | ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES [ Time Frame: End of treatment, up to 48 weeks ] |
6. Secondary: | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO [ Time Frame: End of treatment, up to 48 weeks ] |
7. Secondary: | AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES [ Time Frame: End of treatment, up to 48 weeks ] |
8. Secondary: | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO [ Time Frame: 12 weeks post treatment, up to 60 weeks ] |
9. Secondary: | ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES [ Time Frame: 12 weeks post treatment, up to 60 weeks ] |
10. Secondary: | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO [ Time Frame: 12 weeks post treatment, up to 60 weeks ] |
11. Secondary: | AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES [ Time Frame: 12 weeks post treatment, up to 60 weeks ] |

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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No text entered. |

Certain Agreements:
Results Point of Contact:
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Results Point of Contact:
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com
Organization: Boehringer Ingelheim
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT01358864 History of Changes |
Other Study ID Numbers: |
1220.7 2010-021715-17 ( EudraCT Number: EudraCT ) |
First Submitted: | May 23, 2011 |
First Posted: | May 24, 2011 |
Results First Submitted: | July 3, 2015 |
Results First Posted: | October 28, 2015 |
Last Update Posted: | August 29, 2016 |