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Trial record 46 of 396 for:    IFNA2 AND RBV AND sustained

Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)

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ClinicalTrials.gov Identifier: NCT00255034
Recruitment Status : Terminated (Recruitment targets were unachievable in the currently available population.)
First Posted : November 17, 2005
Results First Posted : July 23, 2009
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Biological: Peginterferon alfa-2b
Drug: Ribavirin
Enrollment 146
Recruitment Details The target recruitment was not attained within the anticipated study time-frame and so study recruitment was ceased on 24 November 2006; however those patients already enrolled in the study continued in the study until completion.
Pre-assignment Details Enrolled 146 subjects; 143 subjects were treated; 3 subjects were withdrawn at Baseline and never received study medication: 1 subject in the 24 weeks group due to consent issues; and 2 subjects in the 48 weeks group (1 subject was ineligible and 1 subject was randomized in error).
Arm/Group Title 24 Weeks of Therapy 48 Weeks of Therapy
Hide Arm/Group Description Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
Period Title: Overall Study
Started 79 64
Completed 64 26
Not Completed 15 38
Reason Not Completed
Withdrawal by Subject             15             38
Arm/Group Title 24 Weeks of Therapy 48 Weeks of Therapy Total
Hide Arm/Group Description Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 79 64 143
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 64 participants 143 participants
40.9  (9.20) 40.5  (9.80) 40.7  (9.44)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 79 participants 64 participants 143 participants
Female 27 12 39
Male 52 51 103
Transgender 0 1 1
1.Primary Outcome
Title Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy
Hide Description No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.
Time Frame 24 weeks after completion of either up to 24 or 48 weeks of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Data were missing for 1 subject in the "48 weeks of therapy" treatment arm.
Arm/Group Title 24 Weeks of Therapy 48 Weeks of Therapy
Hide Arm/Group Description:
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
Overall Number of Participants Analyzed 79 63
Measure Type: Number
Unit of Measure: Participants
55 36
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 24 Weeks of Therapy 48 Weeks of Therapy
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
24 Weeks of Therapy 48 Weeks of Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
24 Weeks of Therapy 48 Weeks of Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/79 (10.13%)      9/64 (14.06%)    
Blood and lymphatic system disorders     
NEUTROPENIA  1  0/79 (0.00%)  0 1/64 (1.56%)  1
Endocrine disorders     
THYROIDITIS  1  0/79 (0.00%)  0 1/64 (1.56%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/79 (0.00%)  0 1/64 (1.56%)  2
ASCITES  1  0/79 (0.00%)  0 1/64 (1.56%)  1
INGUINAL HERNIA  1  0/79 (0.00%)  0 1/64 (1.56%)  1
SALIVARY GLAND CALCULUS  1  1/79 (1.27%)  1 0/64 (0.00%)  0
General disorders     
ABASIA  1  1/79 (1.27%)  1 0/64 (0.00%)  0
Hepatobiliary disorders     
BUDD-CHIARI SYNDROME  1  0/79 (0.00%)  0 1/64 (1.56%)  1
Infections and infestations     
ABDOMINAL ABSCESS  1  1/79 (1.27%)  1 0/64 (0.00%)  0
CELLULITIS  1  2/79 (2.53%)  2 0/64 (0.00%)  0
MENINGITIS VIRAL  1  1/79 (1.27%)  1 0/64 (0.00%)  0
SIALOADENITIS  1  1/79 (1.27%)  1 0/64 (0.00%)  0
URINARY TRACT INFECTION  1  1/79 (1.27%)  1 0/64 (0.00%)  0
WOUND INFECTION  1  1/79 (1.27%)  1 0/64 (0.00%)  0
Injury, poisoning and procedural complications     
ANKLE FRACTURE  1  0/79 (0.00%)  0 1/64 (1.56%)  1
NECK INJURY  1  0/79 (0.00%)  0 1/64 (1.56%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  0/79 (0.00%)  0 1/64 (1.56%)  1
Nervous system disorders     
DIZZINESS  1  1/79 (1.27%)  2 0/64 (0.00%)  0
SYNCOPE  1  1/79 (1.27%)  1 0/64 (0.00%)  0
TARDIVE DYSKINESIA  1  1/79 (1.27%)  1 0/64 (0.00%)  0
Psychiatric disorders     
ANXIETY  1  1/79 (1.27%)  1 0/64 (0.00%)  0
CONFUSIONAL STATE  1  1/79 (1.27%)  1 0/64 (0.00%)  0
DELUSIONAL DISORDER, PERSECUTORY TYPE  1  0/79 (0.00%)  0 1/64 (1.56%)  1
DEPRESSION  1  2/79 (2.53%)  2 0/64 (0.00%)  0
HYPOMANIA  1  1/79 (1.27%)  1 0/64 (0.00%)  0
SUICIDAL IDEATION  1  1/79 (1.27%)  1 0/64 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  1/79 (1.27%)  1 0/64 (0.00%)  0
Skin and subcutaneous tissue disorders     
ECZEMA  1  0/79 (0.00%)  0 1/64 (1.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
24 Weeks of Therapy 48 Weeks of Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/79 (100.00%)      64/64 (100.00%)    
Blood and lymphatic system disorders     
ANAEMIA  1  3/79 (3.80%)  3 5/64 (7.81%)  6
NEUTROPENIA  1  2/79 (2.53%)  2 7/64 (10.94%)  9
Cardiac disorders     
PALPITATIONS  1  2/79 (2.53%)  2 4/64 (6.25%)  4
Eye disorders     
DRY EYE  1  2/79 (2.53%)  2 4/64 (6.25%)  4
VISION BLURRED  1  3/79 (3.80%)  3 7/64 (10.94%)  7
Gastrointestinal disorders     
ABDOMINAL DISTENSION  1  4/79 (5.06%)  4 0/64 (0.00%)  0
ABDOMINAL PAIN  1  4/79 (5.06%)  4 3/64 (4.69%)  3
CHEILITIS  1  5/79 (6.33%)  6 2/64 (3.13%)  2
CONSTIPATION  1  9/79 (11.39%)  10 5/64 (7.81%)  5
DIARRHOEA  1  18/79 (22.78%)  18 8/64 (12.50%)  11
DRY MOUTH  1  8/79 (10.13%)  8 5/64 (7.81%)  5
MOUTH ULCERATION  1  6/79 (7.59%)  7 3/64 (4.69%)  3
NAUSEA  1  28/79 (35.44%)  34 25/64 (39.06%)  27
TOOTHACHE  1  3/79 (3.80%)  4 4/64 (6.25%)  4
VOMITING  1  9/79 (11.39%)  13 6/64 (9.38%)  8
General disorders     
CHEST PAIN  1  0/79 (0.00%)  0 4/64 (6.25%)  4
CHILLS  1  13/79 (16.46%)  14 10/64 (15.63%)  10
FATIGUE  1  38/79 (48.10%)  40 30/64 (46.88%)  34
INFLUENZA LIKE ILLNESS  1  40/79 (50.63%)  40 41/64 (64.06%)  47
INJECTION SITE ERYTHEMA  1  15/79 (18.99%)  15 14/64 (21.88%)  14
IRRITABILITY  1  20/79 (25.32%)  24 20/64 (31.25%)  20
PYREXIA  1  7/79 (8.86%)  7 4/64 (6.25%)  4
THIRST  1  5/79 (6.33%)  5 1/64 (1.56%)  1
Infections and infestations     
LOWER RESPIRATORY TRACT INFECTION  1  2/79 (2.53%)  2 4/64 (6.25%)  4
NASOPHARYNGITIS  1  7/79 (8.86%)  8 1/64 (1.56%)  1
ORAL CANDIDIASIS  1  4/79 (5.06%)  4 0/64 (0.00%)  0
UPPER RESPIRATORY TRACT INFECTION  1  6/79 (7.59%)  6 3/64 (4.69%)  3
Investigations     
WEIGHT DECREASED  1  6/79 (7.59%)  6 8/64 (12.50%)  9
Metabolism and nutrition disorders     
ANOREXIA  1  3/79 (3.80%)  3 4/64 (6.25%)  4
DECREASED APPETITE  1  22/79 (27.85%)  26 14/64 (21.88%)  14
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  13/79 (16.46%)  14 9/64 (14.06%)  12
BACK PAIN  1  12/79 (15.19%)  13 12/64 (18.75%)  14
MYALGIA  1  24/79 (30.38%)  31 12/64 (18.75%)  15
PAIN IN EXTREMITY  1  2/79 (2.53%)  2 6/64 (9.38%)  7
Nervous system disorders     
DISTURBANCE IN ATTENTION  1  7/79 (8.86%)  7 8/64 (12.50%)  9
DIZZINESS  1  8/79 (10.13%)  9 9/64 (14.06%)  11
DYSGEUSIA  1  5/79 (6.33%)  5 4/64 (6.25%)  4
HEADACHE  1  40/79 (50.63%)  51 34/64 (53.13%)  41
LETHARGY  1  18/79 (22.78%)  21 17/64 (26.56%)  20
MEMORY IMPAIRMENT  1  5/79 (6.33%)  5 4/64 (6.25%)  4
Psychiatric disorders     
ANXIETY  1  6/79 (7.59%)  6 10/64 (15.63%)  12
DEPRESSED MOOD  1  5/79 (6.33%)  5 5/64 (7.81%)  6
DEPRESSION  1  20/79 (25.32%)  21 17/64 (26.56%)  20
INSOMNIA  1  30/79 (37.97%)  33 19/64 (29.69%)  21
MOOD SWINGS  1  7/79 (8.86%)  7 10/64 (15.63%)  10
SLEEP DISORDER  1  4/79 (5.06%)  4 10/64 (15.63%)  12
Respiratory, thoracic and mediastinal disorders     
COUGH  1  10/79 (12.66%)  10 6/64 (9.38%)  6
DYSPNOEA  1  15/79 (18.99%)  16 8/64 (12.50%)  9
DYSPNOEA EXERTIONAL  1  4/79 (5.06%)  4 3/64 (4.69%)  3
EPISTAXIS  1  3/79 (3.80%)  3 5/64 (7.81%)  6
NASAL CONGESTION  1  4/79 (5.06%)  5 1/64 (1.56%)  1
PHARYNGOLARYNGEAL PAIN  1  7/79 (8.86%)  8 5/64 (7.81%)  5
PRODUCTIVE COUGH  1  4/79 (5.06%)  5 0/64 (0.00%)  0
Skin and subcutaneous tissue disorders     
ALOPECIA  1  15/79 (18.99%)  16 11/64 (17.19%)  11
DRY SKIN  1  15/79 (18.99%)  15 9/64 (14.06%)  11
ECZEMA  1  3/79 (3.80%)  4 5/64 (7.81%)  5
PRURITUS  1  15/79 (18.99%)  17 10/64 (15.63%)  12
RASH  1  14/79 (17.72%)  15 16/64 (25.00%)  21
RASH PRURITIC  1  9/79 (11.39%)  12 3/64 (4.69%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfill the recruitment target.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice Predsident, 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: NCT00255034     History of Changes
Other Study ID Numbers: P04143
First Submitted: November 15, 2005
First Posted: November 17, 2005
Results First Submitted: June 4, 2009
Results First Posted: July 23, 2009
Last Update Posted: April 6, 2017