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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. ]
  Show Outcome Measure 1


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

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

Serious Adverse Events
  Standard Therapy (48-week Treatment)
Total, serious adverse events  
# participants affected / at risk 93/1427 (6.52%)  
Blood and lymphatic system disorders  
ANAEMIA   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
FEBRILE NEUTROPENIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
PANCYTOPENIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Cardiac disorders  
ATRIOVENTRICULAR BLOCK COMPLETE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
ATRIOVENTRICULAR BLOCK SECOND DEGREE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
BRADYCARDIA   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
MYOCARDIAL INFARCTION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
PALPITATIONS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
PERICARDIAL EFFUSION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SINUS BRADYCARDIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Ear and labyrinth disorders  
VERTIGO   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
Endocrine disorders  
AUTOIMMUNE THYROIDITIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HYPERTHYROIDISM   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
HYPOTHYROIDISM   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
THYROIDITIS SUBACUTE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Eye disorders  
RETINAL DETACHMENT   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
RETINAL TEAR   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
VISUAL DISTURBANCE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Gastrointestinal disorders  
ABDOMINAL PAIN LOWER   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
COLITIS ULCERATIVE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CONSTIPATION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
GASTRITIS EROSIVE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
INTESTINAL OBSTRUCTION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
INTUSSUSCEPTION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
NAUSEA   † A
      # participants affected / at risk
      # events
4/1427 (0.28%)
4  
PANCREATITIS NECROTISING   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SMALL INTESTINAL OBSTRUCTION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
VOLVULUS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
VOMITING   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
General disorders  
ASTHENIA   † A
      # participants affected / at risk
      # events
4/1427 (0.28%)
5  
PAIN   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
PYREXIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Hepatobiliary disorders  
CHOLECYSTITIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CHOLECYSTITIS ACUTE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CHOLELITHIASIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
JAUNDICE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Immune system disorders  
HYPERSENSITIVITY   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Infections and infestations  
ABSCESS LIMB   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
ABSCESS ORAL   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
APPENDICITIS   † A
      # participants affected / at risk
      # events
4/1427 (0.28%)
4  
CELLULITIS   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
CYTOMEGALOVIRUS INFECTION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
INFLUENZA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
INJECTION SITE ABSCESS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
INJECTION SITE CELLULITIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
LOBAR PNEUMONIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
ORCHITIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
PNEUMONIA   † A
      # participants affected / at risk
      # events
4/1427 (0.28%)
4  
PULMONARY TUBERCULOSIS   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
PYELONEPHRITIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SALMONELLOSIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SEPTIC SHOCK   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SYPHILIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
URINARY TRACT INFECTION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Injury, poisoning and procedural complications  
ALCOHOL POISONING   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CLAVICLE FRACTURE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CONCUSSION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CONTUSION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
DISLOCATION OF VERTEBRA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
DRUG TOXICITY   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
INJURY   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
MULTIPLE DRUG OVERDOSE INTENTIONAL   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
ROAD TRAFFIC ACCIDENT   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SCAPULA FRACTURE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
UPPER LIMB FRACTURE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Investigations  
ARTERIOGRAM   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HEART RATE INCREASED   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
PLATELET COUNT DECREASED   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
WHITE BLOOD CELL COUNT DECREASED   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Metabolism and nutrition disorders  
DIABETES MELLITUS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
2  
HYPERCALCAEMIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HYPOGLYCAEMIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HYPONATRAEMIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Musculoskeletal and connective tissue disorders  
ARTHRALGIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
ARTHRITIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
BACK PAIN   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
UNEQUAL LIMB LENGTH   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  
CERVIX CARCINOMA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HEPATIC NEOPLASM MALIGNANT   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
PARATHYROID TUMOUR BENIGN   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
UTERINE LEIOMYOMA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Nervous system disorders  
CAROTID ARTERY DISSECTION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CAROTID ARTERY OCCLUSION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CEREBRAL INFARCTION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
CONVULSION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
EPILEPSY   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
GRAND MAL CONVULSION   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
HEADACHE   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
MEMORY IMPAIRMENT   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
MIGRAINE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
NERVOUS SYSTEM DISORDER   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
PARKINSONISM   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SYNCOPE   † A
      # participants affected / at risk
      # events
3/1427 (0.21%)
3  
SYNCOPE VASOVAGAL   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
TREMOR   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Pregnancy, puerperium and perinatal conditions  
ABORTION SPONTANEOUS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Psychiatric disorders  
ALCOHOLISM   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
ANXIETY   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
BIPOLAR DISORDER   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
COMPLETED SUICIDE   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
DELIRIUM   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
DEPRESSION   † A
      # participants affected / at risk
      # events
4/1427 (0.28%)
4  
HALLUCINATION, AUDITORY   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HALLUCINATION, VISUAL   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HOMICIDAL IDEATION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
PANIC ATTACK   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
PARANOIA   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
PSYCHOTIC DISORDER   † A
      # participants affected / at risk
      # events
2/1427 (0.14%)
2  
SUICIDAL IDEATION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SUICIDE ATTEMPT   † A
      # participants affected / at risk
      # events
3/1427 (0.21%)
3  
Renal and urinary disorders  
OLIGURIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Reproductive system and breast disorders  
METRORRHAGIA   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Respiratory, thoracic and mediastinal disorders  
BRONCHITIS CHRONIC   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
DYSPNOEA EXERTIONAL   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HAEMOPNEUMOTHORAX   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
HAEMOPTYSIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
INTERSTITIAL LUNG DISEASE   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
OBLITERATIVE BRONCHIOLITIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Skin and subcutaneous tissue disorders  
ECZEMA NUMMULAR   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
SKIN LESION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Surgical and medical procedures  
ANAL FISSURE EXCISION   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
Vascular disorders  
THROMBOSIS   † A
      # participants affected / at risk
      # events
1/1427 (0.07%)
1  
† Indicates events were collected by systematic assessment.
A Term from vocabulary, MedDRA 10.0


  Other Adverse Events
  Show 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 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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