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)

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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

Participant Flow

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
Arm/Group Description	PEG-IFN was administered to partici...
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.

Baseline Characteristics

Arm/Group Title		PEG-IFN + Ribavirin
Arm/Group Description		PEG-IFN was administered to partici...
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
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With Sustained Virologic Response (SVR) at 24 Weeks After the End of Treatment (EOT) or Discontinuation
Description	SVR was defined as a vir...
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)

Outcome Measure Data

Analysis Population Description

All treated Participants


Arm/Group Title	PEG-IFN + Ribavirin
Arm/Group Description:	PEG-IFN was administered to partici...
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
Description	Prespecified adverse event discontinuance criteria included neutrophil...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	PEG-IFN + Ribavirin
Arm/Group Description:	PEG-IFN was administered to partici...
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
Description	HCV-RNA negativity was assessed by an RT-PCR method, where a negative ...
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)

Outcome Measure Data

Analysis Population Description

All treated Participants


Arm/Group Title	PEG-IFN + Ribavirin
Arm/Group Description:	PEG-IFN was administered to partici...
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

Adverse Events

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

Arm/Group Title	PEG-IFN + Ribavirin
Arm/Group Description	PEG-IFN was administered to partici...
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	--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

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