Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santaris Pharma A/S
ClinicalTrials.gov Identifier:
NCT01200420
First received: September 9, 2010
Last updated: January 26, 2012
Last verified: January 2012

September 9, 2010
January 26, 2012
September 2010
December 2011   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: regularly over 18 weeks ] [ Designated as safety issue: Yes ]
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, 12 lead and ECG monitoring.
Same as current
Complete list of historical versions of study NCT01200420 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics [ Time Frame: continuously over 4 weeks ] [ Designated as safety issue: No ]
    Appropriate PK parameters, e.g. maximum observed plasma drug concentrations, area under the plasma concentration-time curves, the apparent terminal rate constant and corresponding half-life for miravirsen.
  • Miravirsen treatment effect on viral titer [ Time Frame: regularly over 18 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (Miravirsen) Administered to Treatment-Naïve Subjects With Chronic Hepatitis C (CHC) Infection

The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C.

Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C
  • Drug: miravirsen
    SC injection
    Other Name: SPC3649
  • Drug: saline
    SC injection
  • Experimental: miravirsen
    Dose escalation study with review of safety data following each cohort.
    Intervention: Drug: miravirsen
  • Placebo Comparator: saline
    Dose escalation study with review of safety data following each cohort.
    Intervention: Drug: saline
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. PubMed PMID: 23534542.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI 18-38 kg/m2
  • 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:

  • Other known cause of liver disease except for CHC
  • 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United States,   Slovakia,   Puerto Rico,   Germany,   Poland
 
NCT01200420
SPC3649-203, 2010-019057-17
Yes
Santaris Pharma A/S
Santaris Pharma A/S
Not Provided
Principal Investigator: Stefan Zeuzem, MD J.W. Goethe University Hospital, Frankfurt
Santaris Pharma A/S
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP