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

Participant Flow

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Pre-assignment Details	Enrolled 146 subjects; 143 subjects were treated; 3 subjects were withdrawn at Baseline and never received study medication: 1 subject in the 24 weeks group due to consent issues; and 2 subjects in the 48 weeks group (1 subject was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
Arm/Group Description	Genotype 3 HCV subjects with high v...	Genotype 3 HCV subjects with high v...
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

Baseline Characteristics

Arm/Group Title		24 Weeks of Therapy	48 Weeks of Therapy	Total
Arm/Group Description		Genotype 3 HCV subjects with high v...	Genotype 3 HCV subjects with high v...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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

Outcome Measures

1.Primary Outcome


Title	Sustained Virological Response (SVR), Defined by Undetectable HCV RNA in Serum at 24 Weeks After Completion of Therapy
Description	No formal comparisons could be made and no conclusions drawn because o...
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

Outcome Measure Data

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
Arm/Group Description:	Genotype 3 HCV subjects with high v...	Genotype 3 HCV subjects with high v...
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	24 Weeks of Therapy		48 Weeks of Therapy
Arm/Group Description	[Not Specified]		[Not Specified]
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	--/--		--/--
Serious Adverse Events 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
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

Limitations and Caveats

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.

More Information

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

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