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Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV (DAHHS-2)

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ClinicalTrials.gov Identifier: NCT02600325
Recruitment Status : Completed
First Posted : November 9, 2015
Results First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bart Rijnders, Erasmus Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Hepatitis C
Human Immunodeficiency Virus
Hepatitis C
Intervention Drug: Grazoprevir/Elbasvir 100mg/50mg
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Grazoprevir/Elbasvir 100mg/50mg
Hide Arm/Group Description

Grazoprevir/elbasvir single tablet regimen (100/50mg)

Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg

Period Title: Overall Study
Started 80
Completed 80
Not Completed 0
Arm/Group Title Treatment Arm
Hide Arm/Group Description G/E 8 weeks
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
47  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
0
   0.0%
Male
80
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
72
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
8
  10.0%
1.Primary Outcome
Title SVR12 (Reinfection Not Considered Failure)
Hide Description Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are not considered failure
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
Hide Arm/Group Description:

Grazoprevir/elbasvir single tablet regimen (100/50mg)

Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg

Overall Number of Participants Analyzed 80
Measure Type: Number
Unit of Measure: participants
79
2.Secondary Outcome
Title SVR12 (Reinfection Equals Failure)
Hide Description Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are considered failure
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group
Hide Arm/Group Description:

Grazoprevir/elbasvir single tablet regimen (100/50mg)

Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg

Overall Number of Participants Analyzed 80
Measure Type: Count of Participants
Unit of Measure: Participants
75
  93.8%
Time Frame 20 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group
Hide Arm/Group Description

Grazoprevir/elbasvir single tablet regimen (100/50mg)

Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg

All-Cause Mortality
Treatment Group
Affected / at Risk (%)
Total   0/80 (0.00%)    
Hide Serious Adverse Events
Treatment Group
Affected / at Risk (%) # Events
Total   2/80 (2.50%)    
Gastrointestinal disorders   
traumatic rectal bleeding  1 [1]  1/80 (1.25%)  1
Musculoskeletal and connective tissue disorders   
Elective low back surgery  1 [1]  1/80 (1.25%)  1
1
Term from vocabulary, CTCAE (2.0)
Indicates events were collected by systematic assessment
[1]
Unrelated SAE
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group
Affected / at Risk (%) # Events
Total   43/80 (53.75%)    
Gastrointestinal disorders   
dyspepsia  1  5/80 (6.25%)  5
General disorders   
Fatique  1  11/80 (13.75%)  11
headache  1  7/80 (8.75%)  7
insomnia  1  7/80 (8.75%)  7
mood changes  1  5/80 (6.25%)  5
concentration impairment  1  4/80 (5.00%)  4
dizziness  1  4/80 (5.00%)  4
1
Term from vocabulary, CTCAE (2.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. B. J. A. Rijnders
Organization: Erasmus MC
Phone: 0
EMail: b.rijnders@erasmusmc.nl
Layout table for additonal information
Responsible Party: Bart Rijnders, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02600325    
Other Study ID Numbers: NL2015-003210-24
First Submitted: November 5, 2015
First Posted: November 9, 2015
Results First Submitted: January 11, 2019
Results First Posted: July 8, 2019
Last Update Posted: July 8, 2019