NCT01200420

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
6 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

September 9, 2010

Last Update Submit

January 26, 2012

Conditions

Hepatitis C

Keywords

AntisensemiR-122 antagonisthost factorCHC

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, 12 lead and ECG monitoring.

    regularly over 18 weeks

Secondary Outcomes (2)

  • Pharmacokinetics

    continuously over 4 weeks

  • Miravirsen treatment effect on viral titer

    regularly over 18 weeks

Study Arms (2)

miravirsen

EXPERIMENTAL

Dose escalation study with review of safety data following each cohort.

Drug: miravirsen

saline

PLACEBO COMPARATOR

Dose escalation study with review of safety data following each cohort.

Drug: saline

Interventions

miravirsenDRUG

SC injection

Also known as: SPC3649
miravirsen
salineDRUG

SC injection

saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Alamo Medical Research

San Antonio, Texas, United States

Location

J.W. Goethe University Hospital

Frankfurt, D-60590, Germany

Location

Academic Medical Center (AMC)

Amsterdam, 22660 1100 D, Netherlands

Location

Erasmus MC University Hospital

Rotterdam, 3015 CE, Netherlands

Location

Klinika Hepatologii i Nabytych Niedoborow Immunologicznych WUM

Warsaw, 01-201, Poland

Location

Fundacion de Investigation de Diego

San Juan, Puerto Rico

Location

FNsP Bratislava, Nemocnica akad.

Bratislava, 833 05, Slovakia

Location

Related Publications (2)

  • 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.

    PMID: 25385103DERIVED

  • 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.

    PMID: 23534542DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

miravirsenSodium Chloride

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Stefan Zeuzem, MD

    J.W. Goethe University Hospital, Frankfurt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

PR(1)SL(1)DE(1)NL(2)US(1)PL(1)