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Trial record 47 of 540 for:    IFNA2 AND RBV

Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)

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: NCT00686777
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : January 18, 2012
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Biological: Pegylated Interferon alfa-2b
Drug: Ribavirin
Enrollment 75
Recruitment Details  
Pre-assignment Details Participants could be discontinued from study by meeting prespecified AE discontinuance criteria defined in the protocol. Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL
Arm/Group Title Pegylated Interferon Alfa-2b (PEG-IFN) + Ribavirin
Hide Arm/Group Description PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Period Title: Overall Study
Started 75
Completed 24 Weeks of Treatment 69
Completed 48 Weeks of Treatment 65
Included in Follow-up (All Treated) 75
Completed 24 Weeks of Follow-up 70
Completed 65 [1]
Not Completed 10
Reason Not Completed
Adverse Event             2
Pregnancy             1
Withdrawal by Subject             2
Discontinuance Criteria (specified AEs)             4
No Visit             1
[1]
Of 10 noncompleters, 6 had AEs including 4 meeting protocol prespecified AE discontinuance criteria.
Arm/Group Title PEG-IFN + Ribavirin
Hide Arm/Group Description PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Overall Number of Baseline Participants 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants
55.1  (9.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants
< 65 yrs 64
≥ 65 yrs 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
Female
70
  93.3%
Male
5
   6.7%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation
Hide Description

SVR was defined as a viral response which was sustained at 24 weeks after the end of treatment as measured by Hepatitis C Virus Ribonucleic Acid (HCV-RNA) negativity.

HCV-RNA negativity was assessed by an reverse transcriptase polymerase chain reaction (RT-PCR) method, where a negative response was defined by a negative qualitative HCV-RNA result.

Time Frame Measured at 24 weeks after the end of treatment (at the end of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Participants
Arm/Group Title PEG-IFN + Ribavirin
Hide Arm/Group Description:
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: percentage of participants
30.7
2.Primary Outcome
Title Number of Participants Discontinuing Treatment
Hide Description Prespecified adverse event discontinuance criteria included neutrophil count <500 /mm3, platelet count <50,000/mm3, and hemoglobin <8.5 g/dL.
Time Frame From time of first treatment to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-IFN + Ribavirin
Hide Arm/Group Description:
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: participants
Due To Decrease in Neutrophil Count 3
Due To Decrease in Neutrophil and Platelet Count 1
Due To Apathy 1
Due To Pleural Effusion 1
Due To Pregnancy of Participant's Partner 1
Due To No Visit 1
Due To Withdrawal by Subject 2
Total Number Discontinued 10
3.Secondary Outcome
Title Percentage of Participants With HCV-RNA Negativity at 24 Weeks of Treatment and at EOT
Hide Description HCV-RNA negativity was assessed by an RT-PCR method, where a negative response was defined by a negative qualitative HCV-RNA result.
Time Frame Measured at 24 weeks of treatment and at EOT (Treatment week 48)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated Participants
Arm/Group Title PEG-IFN + Ribavirin
Hide Arm/Group Description:
PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: percentage of participants
At 24 Weeks Treatment 61.3
At End of Treatment 66.7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEG-IFN + Ribavirin
Hide Arm/Group Description PEG-IFN was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
All-Cause Mortality
PEG-IFN + Ribavirin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN + Ribavirin
Affected / at Risk (%) # Events
Total   7/75 (9.33%)    
Congenital, familial and genetic disorders   
MENINGOCELE  1  1/75 (1.33%)  1
Ear and labyrinth disorders   
VERTIGO  1  1/75 (1.33%)  1
Eye disorders   
CATARACT  1  1/75 (1.33%)  1
Gastrointestinal disorders   
COLITIS ISCHAEMIC  1  1/75 (1.33%)  1
Infections and infestations   
LABYRINTHITIS  1  1/75 (1.33%)  1
Investigations   
NEUTROPHIL COUNT DECREASED  1  1/75 (1.33%)  1
Nervous system disorders   
CEREBRAL VENTRICLE DILATATION  1  1/75 (1.33%)  1
Pregnancy, puerperium and perinatal conditions   
PREMATURE BABY  1  1/75 (1.33%)  1
THREATENED LABOUR  1  1/75 (1.33%)  1
Psychiatric disorders   
DEPRESSION  1  1/75 (1.33%)  1
SCHIZOPHRENIA  1  1/75 (1.33%)  1
SUICIDE ATTEMPT  1  1/75 (1.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN + Ribavirin
Affected / at Risk (%) # Events
Total   75/75 (100.00%)    
Blood and lymphatic system disorders   
ANAEMIA  1  4/75 (5.33%)  4
Cardiac disorders   
PALPITATIONS  1  4/75 (5.33%)  6
Ear and labyrinth disorders   
TINNITUS  1  7/75 (9.33%)  7
VERTIGO  1  4/75 (5.33%)  5
Eye disorders   
ABNORMAL SENSATION IN EYE  1  8/75 (10.67%)  8
ASTHENOPIA  1  8/75 (10.67%)  10
DRY EYE  1  5/75 (6.67%)  5
RETINOPATHY  1  4/75 (5.33%)  4
Gastrointestinal disorders   
ABDOMINAL DISCOMFORT  1  18/75 (24.00%)  20
ABDOMINAL DISTENSION  1  4/75 (5.33%)  5
ABDOMINAL PAIN  1  12/75 (16.00%)  18
ABDOMINAL PAIN UPPER  1  13/75 (17.33%)  15
CHEILITIS  1  5/75 (6.67%)  5
CONSTIPATION  1  16/75 (21.33%)  17
DIARRHOEA  1  26/75 (34.67%)  43
GASTRITIS  1  6/75 (8.00%)  6
NAUSEA  1  44/75 (58.67%)  57
STOMATITIS  1  29/75 (38.67%)  36
VOMITING  1  15/75 (20.00%)  21
General disorders   
CHEST PAIN  1  4/75 (5.33%)  4
CHILLS  1  11/75 (14.67%)  11
FATIGUE  1  5/75 (6.67%)  5
FEELING COLD  1  7/75 (9.33%)  7
INJECTION SITE ERYTHEMA  1  30/75 (40.00%)  30
INJECTION SITE PRURITUS  1  26/75 (34.67%)  26
INJECTION SITE RASH  1  11/75 (14.67%)  12
MALAISE  1  66/75 (88.00%)  84
PAIN  1  4/75 (5.33%)  4
PYREXIA  1  73/75 (97.33%)  98
THIRST  1  10/75 (13.33%)  11
Infections and infestations   
CYSTITIS  1  4/75 (5.33%)  4
NASOPHARYNGITIS  1  35/75 (46.67%)  51
PHARYNGITIS  1  4/75 (5.33%)  4
Injury, poisoning and procedural complications   
CONTUSION  1  4/75 (5.33%)  4
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  22/75 (29.33%)  22
ASPARTATE AMINOTRANSFERASE INCREASED  1  22/75 (29.33%)  23
BASOPHIL COUNT INCREASED  1  14/75 (18.67%)  16
BILIRUBIN CONJUGATED INCREASED  1  5/75 (6.67%)  5
BLOOD ALBUMIN DECREASED  1  4/75 (5.33%)  5
BLOOD LACTATE DEHYDROGENASE INCREASED  1  5/75 (6.67%)  5
BLOOD PHOSPHORUS DECREASED  1  8/75 (10.67%)  9
BLOOD POTASSIUM DECREASED  1  14/75 (18.67%)  15
BLOOD THYROID STIMULATING HORMONE DECREASED  1  8/75 (10.67%)  10
BLOOD THYROID STIMULATING HORMONE INCREASED  1  17/75 (22.67%)  18
C-REACTIVE PROTEIN INCREASED  1  6/75 (8.00%)  8
EOSINOPHIL COUNT INCREASED  1  20/75 (26.67%)  28
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  16/75 (21.33%)  16
HAEMATOCRIT DECREASED  1  58/75 (77.33%)  62
HAEMOGLOBIN DECREASED  1  58/75 (77.33%)  65
LYMPHOCYTE COUNT DECREASED  1  71/75 (94.67%)  83
LYMPHOCYTE COUNT INCREASED  1  21/75 (28.00%)  24
MONOCYTE COUNT INCREASED  1  4/75 (5.33%)  7
NEUTROPHIL COUNT DECREASED  1  69/75 (92.00%)  90
NEUTROPHIL COUNT INCREASED  1  8/75 (10.67%)  14
PLATELET COUNT DECREASED  1  43/75 (57.33%)  53
RED BLOOD CELL COUNT DECREASED  1  59/75 (78.67%)  63
RETICULOCYTE PERCENTAGE DECREASED  1  7/75 (9.33%)  10
RETICULOCYTE PERCENTAGE INCREASED  1  34/75 (45.33%)  43
THYROXINE FREE DECREASED  1  6/75 (8.00%)  6
TRI-IODOTHYRONINE FREE DECREASED  1  8/75 (10.67%)  9
TRI-IODOTHYRONINE FREE INCREASED  1  5/75 (6.67%)  5
WEIGHT DECREASED  1  34/75 (45.33%)  35
WHITE BLOOD CELL COUNT DECREASED  1  73/75 (97.33%)  83
Metabolism and nutrition disorders   
DECREASED APPETITE  1  54/75 (72.00%)  66
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  50/75 (66.67%)  63
BACK PAIN  1  18/75 (24.00%)  20
MUSCULOSKELETAL STIFFNESS  1  9/75 (12.00%)  9
MYALGIA  1  49/75 (65.33%)  64
Nervous system disorders   
DIZZINESS  1  17/75 (22.67%)  23
DIZZINESS POSTURAL  1  5/75 (6.67%)  6
DYSGEUSIA  1  17/75 (22.67%)  18
HEADACHE  1  68/75 (90.67%)  86
HYPOAESTHESIA  1  5/75 (6.67%)  7
Psychiatric disorders   
INSOMNIA  1  43/75 (57.33%)  56
MOOD ALTERED  1  4/75 (5.33%)  5
Respiratory, thoracic and mediastinal disorders   
COUGH  1  16/75 (21.33%)  19
DYSPNOEA  1  5/75 (6.67%)  5
EPISTAXIS  1  4/75 (5.33%)  4
OROPHARYNGEAL DISCOMFORT  1  4/75 (5.33%)  4
OROPHARYNGEAL PAIN  1  12/75 (16.00%)  19
PRODUCTIVE COUGH  1  6/75 (8.00%)  7
UPPER RESPIRATORY TRACT INFLAMMATION  1  6/75 (8.00%)  8
Skin and subcutaneous tissue disorders   
ALOPECIA  1  63/75 (84.00%)  64
DRY SKIN  1  6/75 (8.00%)  6
ECZEMA  1  10/75 (13.33%)  10
PRURITUS  1  36/75 (48.00%)  41
PRURITUS GENERALISED  1  12/75 (16.00%)  12
RASH  1  41/75 (54.67%)  49
RASH GENERALISED  1  7/75 (9.33%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686777     History of Changes
Other Study ID Numbers: P05172
JPC-06-320-40
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: December 12, 2011
Results First Posted: January 18, 2012
Last Update Posted: April 7, 2017