Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NL-OMON34513
NL-OMON34513CompletedPhase 2

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 - SPC3649 multiple-dose study

Santaris Pharma A/S0 sites16 target enrollmentStarted: TBDLast updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
16
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1. Male or female, age 18 to 65 years, inclusive
  • •2. BMI 18-38 kg/m2
  • •3. Treatment-naïve to interferon-alpha based therapies
  • •4. HCV genotype 1
  • •5. Clinical and laboratory findings consistent with a clinical diagnosis of Chronic Hepatitis C (CHC), including:
  • •a. Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment,
  • •b. 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
  • •6. Serum HCV RNA > 75,000 IU/mL at Screening
  • •7. Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met:
  • •a. Platelets >100,000/mm3
  • •b. Total WBC > 3000/mm3 and ANC >1500/mm3
  • •c. Hemoglobin > 11 g/dL for females and > 12 g/dL for males
  • •d. Total and direct bilirubin, WNL (except for clearly documented Gilbert*s Syndrome)
  • •e. ALT < 3 x ULN
  • •f. Serum creatinine WNL and estimated creatinine clearance rate as calculated by the Cockcroft-Gault formula > 80 ml/min
  • •8. 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.
  • •9. 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.
  • •For female study participants, adequate birth control methods will be defined as: intrauterine device or double barrier contraception, i.e., condom plus diaphragm, condom or diaphragm plus spermicidal gel /foam.
  • •For males study participants, adequate birth control methods will be defined as: double barrier contraception, i.e., condom plus diaphragm; condom or diaphragm plus spermicidal gel/foam. ;Note: Females who are not of childbearing potential must meet one of the following criteria:
  • •Post-menopause - defined as one year without menses or follicle-stimulating hormone (FSH) of >40 U/mL
  • •Surgical menopause - hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.

Exclusion Criteria

  • •Subjects who meet any of the following criteria at Screening are not eligible to participate in this study:
  • •1. Other known cause of liver disease except for CHC
  • •2. 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
  • •3. History of hepatocellular carcinoma (HCC) on imaging studies or serum alpha-fetoprotein (AFP) > 50 ng/mL at Screening
  • •4. Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results
  • •5. Concurrent social conditions (e.g. drugs, alcohol, transportation) which would potentially interfere with the subject*s study compliance
  • •6. Clinically significant illness within 30 days preceding entry into the study
  • •7. Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication.

Investigators

Sponsor
Santaris Pharma A/S

Similar Trials

Active, not recruiting
Phase 1
Randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of ANB019 in the treatment of Aniceiform Rash in patients with Cancer receiving EGFRi or MEKi therapyAcneiform RashMedDRA version: 21.0Level: LLTClassification code 10037847Term: Rash acneiformSystem Organ Class: 100000004858
EUCTR2020-003494-22-CZAnaptysBio Inc.45
Active, not recruiting
Not Applicable
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug TherapyMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid Arthritis
EUCTR2008-004754-33-CZBiogen Idec Limited150
Active, not recruiting
Phase 1
A study to examine the effectiveness and safety of a experimental new treatment (AMG 714) for adult patients with Type II Refractory Celiac Disease.Type II Refractory Celiac Disease (RCD-II)
EUCTR2015-004063-36-ESCelimmune LLC28
Active, not recruiting
Not Applicable
Efficacy and Safety Study in Mild Asthmatic Subjects Undergoing Allergen ChallengeMild asthma with allergen challengeMedDRA version: 16.1Level: LLTClassification code 10003561Term: Asthma, unspecifiedSystem Organ Class: 100000004855
EUCTR2012-001729-28-DEInfinity Pharmaceuticals, Inc.54
Active, not recruiting
Phase 1
Randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of ANB019 in the treatment of Aniceiform Rash in patients with Cancer receiving EGFRi or MEKi therapy
EUCTR2020-003494-22-BGAnaptysBio Inc.45
A Phase 2a, Randomized, Double-Blind,... | Clinical Trial