A Study to Investigate HCV Response Rates in Real World Patients: HEARTLAND Study

NCT03710252 | Completed Phase 4

• 1 other identifier: TLI_IIS_01_2015
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.

  Primary Analysis

  12 weeks after last treatment

Secondary Outcomes (3)

• Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)

  12 weeks after last treatment

• Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not)

  12 weeks after last treatment

• Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)

  12 weeks after last treatment

Study Arms (1)

Single

EXPERIMENTAL

Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV)

Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin

Interventions

paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin DRUG

OMB/PTV/r + DSV +/- RBV

Single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patients must have chronic GT 1 HCV infection (GT1a, GT1b or GT1a/1b)
• Patient and partner(s) must agree to use acceptable methods of contraception
• Patient must be able to read and understand English and/or Spanish
• Written informed consent

You may not qualify if:

• Currently taking or planning on taking any prohibited medications (see US PI)
• Evidence of decompensated liver disease (Child-Pugh B or C) including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
• Abnormal lab values, including:
• Hemoglobin (Hgb) \<8 g/dL
• Platelets \<25,000 cells/mm3
• Absolute neutrophil count (ANC)\<500 cells/mm3
• Bilirubin \>3
• INR\>2.3 ALT/AST \> 10 x ULN
• Serum albumin \<2.8
• GFR \<30 mL
• Alcohol use: \>3 drinks per day consistently
• Uncontrolled HIV or HBV coinfection

Sponsors & Collaborators

• American Research Corporation: lead
• AbbVie: collaborator

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

paritaprevir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fred Poordad, MD

  American Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This is a Phase IV, open label, single arm study.

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 18, 2018
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 18, 2018

Record last verified: 2018-10