Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01017575

First received: November 19, 2009

Last updated: August 13, 2015

Last verified: August 2015

History of Changes

Results First Received: August 13, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hepatitis C Infection
Interventions:	Drug: Daclatasvir Drug: Placebo Drug: Peginterferon alfa-2a 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
The study was conducted at 6 sites in Japan.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 55 participants were enrolled, of which 43 participants were randomized and 42 were treated. 12 participants were not randomized because 10 no longer met study criteria and 2 withdrew consent; 1 randomized participant was not treated due enlarged lymph node.

Reporting Groups

	Description
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)	Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)	Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)	Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.

Participant Flow: Overall Study

	Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)	Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)	Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
STARTED	8	9	8	8	9
COMPLETED	7	7	8	7	6
NOT COMPLETED	1	2	0	1	3
Lack of Efficacy	0	1	0	1	1
Adverse Event	0	1	0	0	2
Withdrawal by Subject	1	0	0	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated participants who received at least 1 dose of study therapy.

Reporting Groups

	Description
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)	Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN containing regimens including pegIFNα-2a/ ribavirin.
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)	Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)	Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
Total	Total of all reporting groups

Baseline Measures

	Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)	Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)	Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)	Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)	Total
Overall Participants Analyzed [Units: Participants]	8	9	8	8	9	42

Age, Customized [Units: Participants]
<65 years	7	8	6	6	8	35
>=65 years	1	1	2	2	1	7

Gender [Units: Participants]
Female	5	5	6	2	4	22
Male	3	4	2	6	5	20

Outcome Measures

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1. Primary:

Percentage of Participants With Extended Rapid Virologic Response (eRVR) [ Time Frame: From Week 4 up to Week 12 ]

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2. Secondary:

Percentage of Participants With Rapid Virologic Response (RVR) [ Time Frame: Week 4 ]

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3. Secondary:

Percentage of Participants With a Complete Early Virologic Response (cEVR) [ Time Frame: Week 12 ]

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4. Secondary:

Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24 [ Time Frame: Follow up Week 12, Follow up Week 24 ]

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5. Other Pre-specified:

Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died. [ Time Frame: From Baseline up to 30 days after last dose of study drug ]

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6. Other Pre-specified:

Number of Participants With Grade 3 to 4 Laboratory Abnormalities [ Time Frame: From screening up to Week 12 (treatment period) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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: Bristol Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single center publications until after disclosure of the clinical trial's primary publication.

Results Point of Contact:

Name/Title: BristolMyers Squibb Study Director
Organization: BristolMyers Squibb International Corporation
e-mail: clinical.trials@bms.com

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01017575 History of Changes
Other Study ID Numbers:	AI444-022
Study First Received:	November 19, 2009
Results First Received:	August 13, 2015
Last Updated:	August 13, 2015

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