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Safety, Tolerability and Efficacy of 12-weeks of Sovaprevir, ACH-3102 and Ribavirin in Treatment-naive GT-1 HCV Subjects

Information source: Achillion Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Sovaprevir (Drug); ACH-3102 (Drug); RBV (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Achillion Pharmaceuticals

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of treatment with sovaprevir, ACH-0143102 and ribavirin in GT1, treatment-naive, HCV subjects.

Clinical Details

Official title: A Phase 2a Trial to Evaluate the Safety, Tolerability and Efficacy of 12 Weeks of Sovaprevir, ACH-0143102 and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotype-1 Viral Infection

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Incidence of Sustained Virologic Response 4 Weeks (SVR4) After the Completion of Treatment.

To Determine the Safety and Tolerability of 12 Weeks of Sovaprevir and 3102 in Combination With Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Viral Infection.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and Females between ages 18 and 65

- Chronic HCV infection

- HCV genotype 1

- HCV RNA > 10,000 IU/mL at screening.

- Female patients must be willing to use two effective methods of contraception,

one of which must be barrier method, during dosing period and six months after last dose of ribavirin. Females of childbearing potential must have a negative pregnancy test at screening and baseline.

- Male patients must be willing to use an effective barrier method of contraception

throughout the dosing period and for six months.

- Signed and dated written informed consent form.

- Willing to participate in all study activities and all study requirements (including

effective contraception) during study period.

- Treatment naïve subjects defined as subjects who have never received pegylated

interferon, RBV, or a direct-acting anti-viral agent for the treatment of chronic HCV infection.

- A liver biopsy within the last 3 years without evidence of cirrhosis.

Exclusion Criteria:

- Body Mass Index (BMI) > 36. 0

- Pregnant or nursing (lactating) females, confirmed by a positive human chorionic

gonadotropin (HCG) laboratory test or females contemplating pregnancy

- Participation in any interventional clinical trial within 35 days prior to first

study medication dose administration on Day 1

- Known HIV-1 or HIV-2 infection/serology and/or positive Hepatitis B Surface Antigen

(HBsAg)

- Use of dietary supplements, grapefruit juice, herbal supplements, CYP2C8 substrates,

CYP3A4 inducers and inhibitors, PGP inducers and substrates, OATP inhibitors and substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days following completion of study meds.

- Clinically significant laboratory abnormality at screening (specified in protocol)

- Other forms of liver disease

- History of severe or uncontrolled psychiatric disease

- History of malignancy of any organ system, treated or untreated within the past 5

years

- History of major organ transplantation

- Use of bone marrow colony stimulating factor agents within 3 months prior to

baseline.

- History of seizure disorder requiring ongoing medical therapy

- History of known coagulopathy including hemophilia

- History of hemoglobinopathy, including sickle cell anemia and thalassemia.

- History of immunologically mediated disease (specified in protocol)

- History of clinical evidence of significant chronic cardiac disease ( specified in

protocol)

- ECG with any clinically significant abnormality.

- Structural or functional cardiac abnormalities (specified in protocol)

- History of COPD, emphysema, or other chronic lung disease.

- Subjects currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol

abuse in the judgement of the investigator

Locations and Contacts

Franco Felizarta, Bakersfield, California 93301, United States

eStudy Site, La Mesa, California 91942, United States

Gastrointestinal Specialists of Georgia, Marietta, Georgia 30060, United States

Toronto Liver Centre, Toronto, Ontario M6H3M1, Canada

Nashville Gastrointestinal Specialists, Nashville, Tennessee 78215, United States

Liver Associates of Texas PA, Houston, Texas 77030, United States

American Research Corporation, San Antonio, Texas 78215, United States

Medical Associates of Central Virginia, Lynchburg, Virginia 24501, United States

Additional Information

Starting date: April 2013
Last updated: February 4, 2015

Page last updated: August 23, 2015

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