Effect of Insulin Resistance on the Safety and Efficacy of Pegylated Interferon and Ribavirin Treatment in HCV (Study P05562)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00705224

First received: June 23, 2008

Last updated: August 9, 2011

Last verified: August 2011

History of Changes

Results First Received: August 9, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Hepatitis C, Chronic Hepatitis C Virus
Interventions:	Biological: Pegylated Interferon Drug: 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Pegylated Interferon and Ribavirin	Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C.

Description

Pegylated Interferon and Ribavirin

Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on hepatitis C virus (HCV) genotype, viral load, activity and stage of hepatitis C.

Participant Flow: Overall Study

	Pegylated Interferon and Ribavirin
STARTED	250
COMPLETED	239
NOT COMPLETED	11
Adverse Event	1
Lack of Efficacy	2
Withdrawal by Subject	3
Lost to Follow-up	5

Baseline Characteristics

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Reporting Groups

	Description
Pegylated Interferon and Ribavirin	Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.

Description

Pegylated Interferon and Ribavirin

Naïve patients with CHC of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.

Baseline Measures

	Pegylated Interferon and Ribavirin
Number of Participants [units: participants]	250
Age [units: years] Mean ± Standard Deviation	36.0 ± 9.78
Gender [units: participants]
Female	104
Male	146

Outcome Measures

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1. Primary:

Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

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2. Secondary:

Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

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3. Secondary:

Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline [ Time Frame: Week 24 or 48 after treatment start ]

Show Outcome Measure 3

4. Secondary:

Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ]

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5. Secondary:

Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline [ Time Frame: Week 12 after treatment start ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	Safety set: All participants who were administered at least one dose of the study treatment.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Pegylated Interferon and Ribavirin	Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.

Description

Pegylated Interferon and Ribavirin

Naïve patients with chronic hepatitis C (CHC) of any genotype treated with a standard treatment regimen of pegylated interferon and ribavirin according to routine clinical practice in Russia. Each dose of pegylated interferon was administered as a subcutaneous injection calculated as 1.5 mcg/kg once a week. The doses were corrected in case adverse events related to pegylated interferon registered. Ribavirin was taken orally as 200 mg gelatinous capsules. The daily dose varied from 800 to 1200 mg (depending on patient's body weight) twice daily in the morning and in the evening with meal. Therapy duration varied from 24 to 48 weeks depending on HCV genotype, viral load, activity and stage of hepatitis C.

Other Adverse Events

	Pegylated Interferon and Ribavirin
Total, other (not including serious) adverse events
# participants affected / at risk	177/250
Blood and lymphatic system disorders
Anaemia ¹
# participants affected / at risk	69/250 (27.60%)
# events	69
Leukopenia ¹
# participants affected / at risk	90/250 (36.00%)
# events	90
Neutropenia ¹
# participants affected / at risk	30/250 (12.00%)
# events	30
Thrombocytopenia ¹
# participants affected / at risk	50/250 (20.00%)
# events	50
General disorders
Asthenia ¹
# participants affected / at risk	31/250 (12.40%)
# events	31
Influenza Like Illness ¹
# participants affected / at risk	91/250 (36.40%)
# events	91
Pyrexia ¹
# participants affected / at risk	17/250 (6.80%)
# events	17
Investigations
Weight Decreased ¹
# participants affected / at risk	26/250 (10.40%)
# events	26
Psychiatric disorders
Depression ¹
# participants affected / at risk	25/250 (10.00%)
# events	25
Skin and subcutaneous tissue disorders
Alopecia ¹
# participants affected / at risk	14/250 (5.60%)
# events	14

1	Term from vocabulary, MedDRA (14.0)

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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: PI agrees for a period of five years following the Effective Date to retain the Disclosure made to the SPONSOR or on behalf of SPONSOR, in confidence and not disclose it to any third party.

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
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Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00705224 History of Changes
Other Study ID Numbers:	P05562
Study First Received:	June 23, 2008
Results First Received:	August 9, 2011
Last Updated:	August 9, 2011
Health Authority:	Russia: Ethics Committee

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