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Trial record 49 of 382 for:    IFNA2 AND RBV AND genotype

Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02508090
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : November 1, 2017
Santaris Pharma A/S
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.

Condition or disease
Chronic Hepatitis C

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin in Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection
Actual Study Start Date : August 2, 2013
Actual Primary Completion Date : January 13, 2017
Actual Study Completion Date : January 13, 2017

Resource links provided by the National Library of Medicine

Study Population
Participants who previously received 12 weeks of miravirsen monotherapy in Study SPC3649-207 will complete up to 36 months of safety and efficacy follow-up without investigational treatment.

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 36 months ]
  2. Incidence of sustained virologic response (SVR) [ Time Frame: 48 weeks after end of treatment (EOT) ]
  3. Change from Baseline in HCV ribonucleic acid (RNA) level [ Time Frame: Up to 36 months ]
  4. Incidence of HCV resistance [ Time Frame: Up to 36 months ]

Biospecimen Retention:   Samples Without DNA
Blood and urine samples will be collected over a course of 7 study visits to obtain hematology, chemistry, urinalysis, coagulation, HCV RNA, and viral resistance data.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll null responders with CHC genotype 1 virus infection who have participated in Study SPC3649-207.

Inclusion Criteria:

  • Participants from Study SPC3649-207, including those who completed the study and those who discontinued or terminated the study early for any reason, or those who opted to receive other approved therapy for the treatment of hepatitis C virus (HCV) infection

Exclusion Criteria:

  • Participants who have received investigational drug therapy after discontinuation, termination, or completion of Study SPC3649-207

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02508090

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Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Hoffmann-La Roche
Santaris Pharma A/S
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT02508090     History of Changes
Obsolete Identifiers: NCT02031133
Other Study ID Numbers: NP29711
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs