Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C (STEALTHC-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00495391
First received: July 2, 2007
Last updated: November 18, 2013
Last verified: May 2012
Results First Received: November 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Hepatitis C
Interventions: Drug: Nitazoxanide
Drug: Placebo
Biological: Peginterferon alfa-2a
Drug: Ribavirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study recruited patients from 10 study sites in the United States, including a Veterans Administrations hospital.

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
NTZ+PR

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo+PR

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.


Participant Flow:   Overall Study
    NTZ+PR     Placebo+PR  
STARTED     42     22  
COMPLETED     6     1  
NOT COMPLETED     36     21  
Lack of Efficacy                 34                 18  
Withdrawal by Subject                 2                 3  



  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
NTZ+PR

Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo+PR

Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.

Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.

Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.

Placebo : One oral placebo tablet twice daily for 52 weeks.

Total Total of all reporting groups

Baseline Measures
    NTZ+PR     Placebo+PR     Total  
Number of Participants  
[units: participants]
  42     22     64  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     39     21     60  
>=65 years     3     1     4  
Age  
[units: years]
Mean ± Standard Deviation
  54  ± 8     53  ± 6     53.5  ± 6.9  
Gender  
[units: participants]
     
Female     13     8     21  
Male     29     14     43  
Region of Enrollment  
[units: participants]
     
United States     42     22     64  



  Outcome Measures
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1.  Primary:   Sustained Virologic Response (HCV RNA Below Lower Limit of Detection)   [ Time Frame: 24 weeks after end of treatment ]

2.  Secondary:   End of Treatment Response (HCV RNA Below Lower Limit of Detection)   [ Time Frame: At end of treatment ]

3.  Secondary:   Early Virologic Response (HCV RNA Below Lower Limit of Detection)   [ Time Frame: After 12 weeks combination treatment ]

4.  Secondary:   Rapid Virologic Response (HCV RNA Below Lower Limit of Detection)   [ Time Frame: After 4 weeks combination treatment ]

5.  Secondary:   Changes in ALT   [ Time Frame: From baseline to week 8 ]

6.  Secondary:   Changes in ALT   [ Time Frame: From baseline to week 16 ]

7.  Secondary:   Changes in ALT   [ Time Frame: From baseline to end of treatment ]

8.  Secondary:   Changes in ALT   [ Time Frame: From baseline to end of follow up ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Marc Ayers
Organization: Romark Laboratories, L.C.
phone: 813-282-8544
e-mail: Marc.Ayers@romark.com


No publications provided


Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT00495391     History of Changes
Other Study ID Numbers: RM01-2025
Study First Received: July 2, 2007
Results First Received: November 18, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration