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Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00687544
First received: May 27, 2008
Last updated: October 31, 2014
Last verified: October 2014
Results First Received: September 22, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hepatitis C, Chronic
Hepacivirus
HIV Infections
Interventions: Biological: Peginterferon alfa-2b (SCH 054031)
Drug: Ribavirin (SCH 018908)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PEG-IFN + RBV Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Participant Flow:   Overall Study
    PEG-IFN + RBV  
STARTED     11  
COMPLETED     0  
NOT COMPLETED     11  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
PEG-IFN + RBV Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Baseline Measures
    PEG-IFN + RBV  
Number of Participants  
[units: participants]
  11  
Age  
[units: Participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     11  
Region of Enrollment  
[units: participants]
 
Indonesia     11  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieved Sustained Virologic Response (SVR)   [ Time Frame: Week 48 or Week 72 (depending on duration of treatment) ]

Measure Type Primary
Measure Title Number of Participants Who Achieved Sustained Virologic Response (SVR)
Measure Description

Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.

SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72).

The study was terminated due to low enrollment. This analysis was not performed.

Time Frame Week 48 or Week 72 (depending on duration of treatment)  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
PEG-IFN + RBV Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Measured Values
    PEG-IFN + RBV  
Number of Participants Analyzed  
[units: participants]
  0  
Number of Participants Who Achieved Sustained Virologic Response (SVR)      

No statistical analysis provided for Number of Participants Who Achieved Sustained Virologic Response (SVR)



2.  Primary:   Number of Participants Who Achieved Virologic Response (VR)   [ Time Frame: 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks) ]

Measure Type Primary
Measure Title Number of Participants Who Achieved Virologic Response (VR)
Measure Description

Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.

The study was terminated due to low enrollment. This analysis was not performed.

Time Frame 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
PEG-IFN + RBV Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Measured Values
    PEG-IFN + RBV  
Number of Participants Analyzed  
[units: participants]
  0  
Number of Participants Who Achieved Virologic Response (VR)      

No statistical analysis provided for Number of Participants Who Achieved Virologic Response (VR)



3.  Primary:   Number of Participants Who Achieved Sustained Biochemical Response (SBR)   [ Time Frame: Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks) ]

Measure Type Primary
Measure Title Number of Participants Who Achieved Sustained Biochemical Response (SBR)
Measure Description

Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.

SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72).

The study was terminated due to low enrollment. This analysis was not performed.

Time Frame Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
PEG-IFN + RBV Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Measured Values
    PEG-IFN + RBV  
Number of Participants Analyzed  
[units: participants]
  0  
Number of Participants Who Achieved Sustained Biochemical Response (SBR)      

No statistical analysis provided for Number of Participants Who Achieved Sustained Biochemical Response (SBR)



4.  Secondary:   Number of Participants Experiencing Opportunistic Infection   [ Time Frame: Throughout the study (up to 72 weeks) ]

Measure Type Secondary
Measure Title Number of Participants Experiencing Opportunistic Infection
Measure Description The study was terminated due to low enrollment. This analysis was not performed.
Time Frame Throughout the study (up to 72 weeks)  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
PEG-IFN + RBV Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Measured Values
    PEG-IFN + RBV  
Number of Participants Analyzed  
[units: participants]
  0  
Number of Participants Experiencing Opportunistic Infection      

No statistical analysis provided for Number of Participants Experiencing Opportunistic Infection



5.  Secondary:   Number of Participants Who Died   [ Time Frame: Throughout the study (up to 72 weeks) ]

Measure Type Secondary
Measure Title Number of Participants Who Died
Measure Description No text entered.
Time Frame Throughout the study (up to 72 weeks)  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
PEG-IFN + RBV Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Measured Values
    PEG-IFN + RBV  
Number of Participants Analyzed  
[units: participants]
  11  
Number of Participants Who Died  
[units: participants]
  0  

No statistical analysis provided for Number of Participants Who Died



6.  Secondary:   Number of Participants Experiencing Adverse Events   [ Time Frame: Throughout the study (up to 72 weeks) ]

Measure Type Secondary
Measure Title Number of Participants Experiencing Adverse Events
Measure Description An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.
Time Frame Throughout the study (up to 72 weeks)  
Safety Issue Yes  

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.
No text entered.

Reporting Groups
  Description
PEG-IFN + RBV Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)

Measured Values
    PEG-IFN + RBV  
Number of Participants Analyzed  
[units: participants]
  11  
Number of Participants Experiencing Adverse Events  
[units: participants]
  10  

No statistical analysis provided for Number of Participants Experiencing Adverse Events




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The study was terminated early due to low enrollment. The primary and secondary outcomes were not evaluated. A formal safety analysis was not performed for the 11 participants enrolled in the study.


  More Information
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Certain Agreements:  
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:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687544     History of Changes
Other Study ID Numbers: P04469
Study First Received: May 27, 2008
Results First Received: September 22, 2011
Last Updated: October 31, 2014
Health Authority: Indonesia: National Agency of Drug and Food Control