Working… Menu

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

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: NCT01200420
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Santaris Pharma A/S

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 13, 2010
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
Safety and tolerability [ Time Frame: regularly over 18 weeks ]
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, 12 lead and ECG monitoring.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
  • Pharmacokinetics [ Time Frame: continuously over 4 weeks ]
    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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Multiple Ascending Dose Study of Miravirsen in Treatment-Naïve Chronic Hepatitis C Subjects
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: miravirsen
    SC injection
    Other Name: SPC3649
  • Drug: saline
    SC injection
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2010)
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands,   Poland,   Puerto Rico,   Slovakia,   United States
Removed Location Countries Romania
Administrative Information
NCT Number  ICMJE NCT01200420
Other Study ID Numbers  ICMJE SPC3649-203
2010-019057-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Santaris Pharma A/S
Study Sponsor  ICMJE Santaris Pharma A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Zeuzem, MD J.W. Goethe University Hospital, Frankfurt
PRS Account Santaris Pharma A/S
Verification Date January 2012

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