Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects
NCT ID: NCT01200420
Last Updated: 2012-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2010-09-30
2011-12-31
Brief Summary
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Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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miravirsen
Dose escalation study with review of safety data following each cohort.
miravirsen
SC injection
saline
Dose escalation study with review of safety data following each cohort.
saline
SC injection
Interventions
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miravirsen
SC injection
saline
SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment-naïve to interferon-alpha based therapies
* HCV genotype 1
* Clinical and laboratory findings consistent with a clinical diagnosis of CHC, including:
Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment, OR Positive HCV serology (HCV antibody or HCV RNA) with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C
* Serum HCV RNA \> 75,000 IU/mL at Screening
* (North American sites only). Liver biopsy within 36 months of Day 1, indicating the absence of cirrhosis
* Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met:
* Platelets \>100,000/mm3
* Total WBC \> 3000/mm3 and ANC \>1500/mm3
* Hemoglobin \> 11 g/dL for females and \> 12 g/dL for males
* Total and direct bilirubin, WNL (except for clearly documented Gilbert's Syndrome)
* ALT \< 5 x ULN
* Serum creatinine WNL and creatinine clearance as calculated by the Cockcroft-Gault formula \> 80 ml/min
* Negative results on the following Screening laboratory tests: urine or serum pregnancy test (for women of childbearing potential), hepatitis B surface antigen and human immunodeficiency virus (HIV) antibody.
* For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to Screening). IUD, Depo-Provera, Norplant System implants, bilateral tubal ligation, vasectomy, condom or diaphragm plus either contraceptive sponge, foam or jelly and abstinence.
Exclusion Criteria
* History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding, fibrosis or other signs of hepatic insufficiency or portal hypertension
* History of hepatocellular carcinoma (HCC) on imaging studies or serum alpha-fetoprotein (AFP) \> 50 ng/mL at Screening
* Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results
* Concurrent social conditions (e.g. drugs, alcohol, transportation) which would potentially interfere with the subject's study compliance
* Clinically significant illness within 30 days preceding entry into the study
* Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication.
18 Years
65 Years
ALL
No
Sponsors
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Santaris Pharma A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Stefan Zeuzem, MD
Role: PRINCIPAL_INVESTIGATOR
J.W. Goethe University Hospital, Frankfurt
Locations
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Alamo Medical Research
San Antonio, Texas, United States
J.W. Goethe University Hospital
Frankfurt, , Germany
Academic Medical Center (AMC)
Amsterdam, , Netherlands
Erasmus MC University Hospital
Rotterdam, , Netherlands
Klinika Hepatologii i Nabytych Niedoborow Immunologicznych WUM
Warsaw, , Poland
Fundacion de Investigation de Diego
San Juan, , Puerto Rico
FNsP Bratislava, Nemocnica akad.
Bratislava, , Slovakia
Countries
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References
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Ottosen S, Parsley TB, Yang L, Zeh K, van Doorn LJ, van der Veer E, Raney AK, Hodges MR, Patick AK. In vitro antiviral activity and preclinical and clinical resistance profile of miravirsen, a novel anti-hepatitis C virus therapeutic targeting the human factor miR-122. Antimicrob Agents Chemother. 2015 Jan;59(1):599-608. doi: 10.1128/AAC.04220-14. Epub 2014 Nov 10.
Janssen HL, Reesink HW, Lawitz EJ, Zeuzem S, Rodriguez-Torres M, Patel K, van der Meer AJ, Patick AK, Chen A, Zhou Y, Persson R, King BD, Kauppinen S, Levin AA, Hodges MR. Treatment of HCV infection by targeting microRNA. N Engl J Med. 2013 May 2;368(18):1685-94. doi: 10.1056/NEJMoa1209026. Epub 2013 Mar 27.
Other Identifiers
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2010-019057-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPC3649-203
Identifier Type: -
Identifier Source: org_study_id