New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C

Completed · Phase 2

Conditions studied: Cirrhosis, Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic

In brief

Background: \- Some people who have chronic hepatitis C do not respond to the usual treatment with peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may work better for different people. The treatments will look at how specific genes interact with the drugs. Researchers want to see how well these new drugs work in people whose chronic hepatitis C has not responded or only partly responded to the usual treatment drugs. Objectives: \- To compare new treatments for people with chronic hepatitis C. Eligibility: \- Individuals at least 18 years of age who have chronic hepatitis C that has not responded to standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Liver scans and a biopsy will be taken before the start of treatment. * Participants will be separated into two groups. One group will have the new treatment drugs (assunaprevir and daclatasvir). The second group will have these two drugs as well as peginterferon and ribavirin. All participants will have an initial 4-day hospital stay with regular blood tests to see how the start of the treatment works. * The first group will take the new study drug tablets daily for 24 weeks. Those who do not respond to this treatment will also start to take peginterferon and ribavirin, and the treatment will continue for 24 weeks after starting the additional drugs. * The second group will take all four drugs according to the standard dosing schedule for 24 weeks. * Treatment will be monitored with frequent blood tests. Liver scans, biopsies, and other tests will be performed as directed by the study doctors. * Participants will have 24 weeks of regular followup visits.

Key facts

Study ID

NCT01888900

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

35

Starts

2013-05-01

Expected to finish

2015-11-01

Last updated by the study team

2017-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Exclusion Criteria for Genotypes 1b:
• Medical History and Concurrent Diseases
• Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair;
• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
• Documented or suspected HCC, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
• Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
• Evidence of a medical condition contributing to chronic liver disease other than HCV (such as, but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg, HBsAg-seropositive). Subjects with resolved HBV infection may participate (eg, HBsAb-seropositive with concurrent HBsAg-seronegative)
• Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug. (Subjects who have had cholecystectomy are permitted to enter the study)
• History of HIV infection
• Hemophilia
• Uncontrolled diabetes (any subject with a confirmed screening HgA1c greater than or equal to 8.5 must be excluded)
• Confirmed, uncontrolled hypertension (any screening systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 100 mmHg should be excluded unless discussed with the central medical monitor)
• Any other medical and/or social reason, including active substance abuse as defined by DSM-IV, Diagnostic Criteria for Drug and Alcohol Abuse, which in the opinion of the investigator would make the candidate inappropriate for participation in this study
• History of severe psychiatric disorders including but not limited to, schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder, mania, etc.
• Inability to tolerate oral medication;
• Poor venous access
• Physical and Laboratory Test Findings
• Note: Growth factors must not be used to achieve eligibility criteria.
• ALT greater than or equal to 10 times ULN
• Total bilirubin greater than or equal to 34 micromoles per liter (greater than or equal to 2 mg/dL) unless the subject has documented history of Gilbert s disease
• Albumin < 3.5 g/dL (35 g/L)
• Creatinine clearance (CrCl) less than or equal to 50 ml/min (as estimated by Cockcroft and Gault)
• Platelets < 50 times 10(9) cells/L
• ANC < 0.5 times 10(9) cells/L

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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