Study of CTS-1027 in Combination With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Null-Responders (CTS-1027-04)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Conatus Pharmaceuticals Inc.

ClinicalTrials.gov Identifier:

NCT01051921

First received: January 18, 2010

Last updated: April 10, 2012

Last verified: April 2012

History of Changes

Results First Received: March 13, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hepatitis C
Interventions:	Drug: CTS-1027 Drug: 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
CTS-1027, Pegylated Interferon, Ribavirin	CTS-1027 plus Pegylated Interferon plus ribavirin

Participant Flow: Overall Study

	CTS-1027, Pegylated Interferon, Ribavirin
STARTED	67
COMPLETED	37
NOT COMPLETED	30
Physician Decision	9
Adverse Event	8
Withdrawal by Subject	7
Lost to Follow-up	4
virological failure	1
patient moved	1

Baseline Characteristics

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Reporting Groups

	Description
CTS-1027, Pegylated Interferon, Ribavirin	CTS-1027 plus Pegylated Interferon plus ribavirin

Baseline Measures

	CTS-1027, Pegylated Interferon, Ribavirin
Number of Participants [units: participants]	67
Age [units: participants]
<=18 years	0
Between 18 and 65 years	65
>=65 years	2
Age [units: years] Mean ± Standard Deviation	52.1 ± 7.9
Gender [units: participants]
Female	18
Male	49
Region of Enrollment [units: participants]
United States	67

Outcome Measures

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1. Primary:

Early Virologic Response (EVR) [ Time Frame: Baseline and Study week 12 ]

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2. Secondary:

> 2 Log Decline in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at 24 Weeks [ Time Frame: Baseline and Study week 24 ]

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Serious Adverse Events

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Time Frame	Day 1 of dosing through 12 week follow-up visit (up to 60 weeks).
Additional Description	Adverse events listed are those reported by at least 5% of the patients, and deemed potentially related (possibly, probably, or definitely) by the Investigator. All serious adverse events are reported regardless of causality.

Reporting Groups

	Description
CTS-1027, Pegylated Interferon, Ribavirin	CTS-1027 plus Pegylated Interferon plus ribavirin

Serious Adverse Events

	CTS-1027, Pegylated Interferon, Ribavirin
Total, serious adverse events
# participants affected / at risk	7/67 (10.45%)
Gastrointestinal disorders
Inguinal hernia, obstructive ^{† 2}
# participants affected / at risk	1/67 (1.49%)
# events	1
Vomiting ^{† 2}
# participants affected / at risk	1/67 (1.49%)
# events	1
General disorders
Chest Pain ^{† 2}
# participants affected / at risk	1/67 (1.49%)
# events	1
Hepatobiliary disorders
Cholecystitis ^{† 2}
# participants affected / at risk	1/67 (1.49%)
# events	1
Infections and infestations
Appendicitis ^{† 1}
# participants affected / at risk	1/67 (1.49%)
# events	1
Pyelonephritis ^{† 2}
# participants affected / at risk	1/67 (1.49%)
# events	1
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain ^{† 2}
# participants affected / at risk	1/67 (1.49%)
# events	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Oncocytoma ^{† 2}
# participants affected / at risk	1/67 (1.49%)
# events	1

†	Events were collected by systematic assessment
1	Term from vocabulary, MeDRA 12.1
2	Term from vocabulary, MedDRA

Other Adverse Events

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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.

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
Although this study was completed, the entire CTS-1027 program was discontinued prior to database lock. Hence, only a safety analysis was carried out for this study. Analysis of the primary and secondary efficacy measures was not completed.

Results Point of Contact:

Name/Title: Vice President, Clinical Development
Organization: Conatus Pharmaceuticals Inc.
phone: (858) 457- 7227
e-mail: MHuyghe@conatuspharma.com

No publications provided

Responsible Party:	Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT01051921 History of Changes
Other Study ID Numbers:	CTS-1027-04
Study First Received:	January 18, 2010
Results First Received:	March 13, 2012
Last Updated:	April 10, 2012
Health Authority:	United States: Food and Drug Administration

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