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Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685AM3)(COMPLETED)
This study has been completed.
Study NCT00265395   Information provided by Schering-Plough
First Received: December 13, 2005   Last Updated: October 28, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment
Condition: Hepatitis C, Chronic
Interventions: Drug: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)
Drug: Combination of pegylated interferon alfa-2b and 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1428 patients enrolled; 159 patients qualified as slow responders per treatment week 12 and 24 protocol-specified eligibility criteria; 159 patients were randomized

Reporting Groups
  Description
Standard Therapy (48-week Treatment) Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
Extended Therapy (72-week Treatment) Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.

Participant Flow:   Overall Study
  Standard Therapy (48-week Treatment) Extended Therapy (72-week Treatment)
STARTED   86     73  
COMPLETED   78     56  
NOT COMPLETED   8     17  
      Adverse Event               3                 6  
      Lost to Follow-up               2                 1  
      Withdrawal by Subject               1                 6  
      Protocol Violation               2                 2  
      Lack of Efficacy               0                 1  
      Administrative               0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Standard Therapy (48-week Treatment) Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
Extended Therapy (72-week Treatment) Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.

Baseline Measures
  Standard Therapy (48-week Treatment) Extended Therapy (72-week Treatment) Total
Number of Participants  
[units: participants]
 		86 73 159
Age  
[units: years]
Mean ± Standard Deviation 		44.5 ± 9.9 46.5 ± 11.6 45.35 ± 10.79
Gender  
[units: participants]
 		     
Female 34 27 61
Male 52 46 98



  Outcome Measures

1.  Primary:   Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.   [ 48 or 72 weeks of treatment plus 24 weeks of follow-up. ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Standard Therapy (48-week Treatment) No text entered.

Other Adverse Events
  Standard Therapy (48-week Treatment)
Total, other (not including serious) adverse events  
# participants affected / at risk 1337  
Blood and lymphatic system disorders  
ANAEMIA   † A
      # participants affected / at risk
      # events
197/1427 (13.81%)
260  
ERYTHROPENIA   † A
      # participants affected / at risk
      # events
74/1427 (5.19%)
96  
LEUKOPENIA   † A
      # participants affected / at risk
      # events
183/1427 (12.82%)
268  
NEUTROPENIA   † A
      # participants affected / at risk
      # events
281/1427 (19.69%)
464  
Gastrointestinal disorders  
ABDOMINAL PAIN UPPER   † A
      # participants affected / at risk
      # events
94/1427 (6.59%)
112  
DIARRHOEA   † A
      # participants affected / at risk
      # events
129/1427 (9.04%)
152  
DRY MOUTH   † A
      # participants affected / at risk
      # events
75/1427 (5.26%)
75  
NAUSEA   † A
      # participants affected / at risk
      # events
254/1427 (17.80%)
301  
General disorders  
ASTHENIA   † A
      # participants affected / at risk
      # events
402/1427 (28.17%)
458  
CHILLS   † A
      # participants affected / at risk
      # events
153/1427 (10.72%)
204  
FATIGUE   † A
      # participants affected / at risk
      # events
338/1427 (23.69%)
412  
INFLUENZA LIKE ILLNESS   † A
      # participants affected / at risk
      # events
599/1427 (41.98%)
843  
INJECTION SITE ERYTHEMA   † A
      # participants affected / at risk
      # events
143/1427 (10.02%)
152  
IRRITABILITY   † A
      # participants affected / at risk
      # events
157/1427 (11.00%)
169  
PYREXIA   † A
      # participants affected / at risk
      # events
421/1427 (29.50%)
834  
Investigations  
HAEMOGLOBIN DECREASED   † A
      # participants affected / at risk
      # events
161/1427 (11.28%)
215  
NEUTROPHIL COUNT DECREASED   † A
      # participants affected / at risk
      # events
106/1427 (7.43%)
171  
WEIGHT DECREASED   † A
      # participants affected / at risk
      # events
150/1427 (10.51%)
169  
WHITE BLOOD CELL COUNT DECREASED   † A
      # participants affected / at risk
      # events
77/1427 (5.40%)
112  
Metabolism and nutrition disorders  
ANOREXIA   † A
      # participants affected / at risk
      # events
156/1427 (10.93%)
160  
DECREASED APPETITE   † A
      # participants affected / at risk
      # events
103/1427 (7.22%)
107  
Musculoskeletal and connective tissue disorders  
ARTHRALGIA   † A
      # participants affected / at risk
      # events
195/1427 (13.67%)
235  
BACK PAIN   † A
      # participants affected / at risk
      # events
91/1427 (6.38%)
106  
MYALGIA   † A
      # participants affected / at risk
      # events
274/1427 (19.20%)
417  
Nervous system disorders  
DISTURBANCE IN ATTENTION   † A
      # participants affected / at risk
      # events
77/1427 (5.40%)
81  
DIZZINESS   † A
      # participants affected / at risk
      # events
115/1427 (8.06%)
128  
HEADACHE   † A
      # participants affected / at risk
      # events
408/1427 (28.59%)
569  
Psychiatric disorders  
DEPRESSION   † A
      # participants affected / at risk
      # events
139/1427 (9.74%)
156  
INSOMNIA   † A
      # participants affected / at risk
      # events
178/1427 (12.47%)
194  
Respiratory, thoracic and mediastinal disorders  
COUGH   † A
      # participants affected / at risk
      # events
195/1427 (13.67%)
213  
DYSPNOEA   † A
      # participants affected / at risk
      # events
111/1427 (7.78%)
124  
Skin and subcutaneous tissue disorders  
ALOPECIA   † A
      # participants affected / at risk
      # events
318/1427 (22.28%)
328  
DRY SKIN   † A
      # participants affected / at risk
      # events
188/1427 (13.17%)
199  
PRURITUS   † A
      # participants affected / at risk
      # events
267/1427 (18.71%)
290  
RASH   † A
      # participants affected / at risk
      # events
177/1427 (12.40%)
211  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 10.0


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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P03685, SUCCESS
Study First Received: December 13, 2005
Results First Received: May 15, 2009
Last Updated: October 28, 2009
ClinicalTrials.gov Identifier: NCT00265395     History of Changes
Health Authority: Spain: Ethics Committee





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