Hepatitis C, ChronicPhase 4NCT03003338

MHH-HCV-NPM-Neuropsychiatric Manifestations of HCV-infection During and After Treatment With OBV/PTV/r and DSV

A Phase 4 study testing OBV/PTV/r and DSV in people with Hepatitis C, Chronic, run by Hannover Medical School at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: OBV/PTV/r and DSV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteGermany
Study dates: 24 Oct 2017to 22 Oct 2018
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing and able to provide written informed consent
Male or female, age ≥18 years
Chronic hepatitis C virus infection
Fatigue Impact Scale Score (FIS) >45 and a sum score (Att Test Sum Score) >0.4 in the battery of attention tests applied.
Female who is:
practicing total abstinence from sexual intercourse (minimum 1 complete menstrual cycle)

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sexually active with female partners only
not of childbearing potential, defined as:
postmenopausal for at least 2 years (defined as amenorrheic for longer than 2 years, age appropriate, and confirmed by a follicle-stimulating hormone [FSH] level indicating a postmenopausal state), or
surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or has a vasectomized partner (s);
of childbearing potential and sexually active with male partner(s):
currently using an effective method of birth control at the time of screening and
agree to practice highly effective methods of birth control while receiving study drugs and at least one effective method of birth control during the follow-up period (see section 4.3). (Note: Ethinylestradiol-containing hormonal contraceptives, including oral, injectable, implantable, patch and ring varieties, may not be used during study drug treatment.)
Females of childbearing potential must have negative results for pregnancy tests performed:
at Screening on a serum specimen obtained within 28 days prior to initial study drug administration, and
on a urine sample obtained on Study Day 1 (prior to dosing).
Males who are not surgically sterile and who are sexually active with female partner(s) of childbearing potential must agree to practice an effective form of birth control (see section 4.3) throughout the course of the study, starting with Study Day 1 and for 30 days after stopping study drug.
Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments.
Body Mass Index (BMI) is > 17 to < 40 kg/m2. BMI is calculated as weight measured in kg divided by the square of height measured in meters (m).
Confirmation of chronic genotype 1b HCV infection documented by the following:
Positive for anti-HCV antibody or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCV antibody at the time of Screening
Per local standard practice, documented results of:
Index (APRI) ≤ 2 at Screening, or
FibroScan® result of < 12 kPa at Screening or
The absence of cirrhosis based on a liver biopsy within the last 36 months.
HCV > RNA 1000 IU/ml at Screening
Subject must be of generally good health as determined by the Investigator.
Subject has not been treated with any investigational drug or device or any commercially available anti-HCV agents within 42 days of the Screening visit.

Who cannot join

Any previous exposure to HCV protease inhibitors, HCV NS5A inhibitors or HCV polymerase inhibitors
History of severe, life threatening or other significant sensitivity to any drug.
Pregnant or nursing female or male with pregnant female partner
Recent (within 6-months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
Infection with hepatitis B virus (HBV; defined as HBsAg-positive) or human immunodeficiency virus (HIV)
Use of any medication that are contraindicated for use with OBV/PTV/r and DSV within 2 weeks prior to study drug administration or 10 half-lives of the medication whichever is longer (see SmPC of OBV/PTV/r and DSV and section 4.4).

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Clinically-significant illness (other than HCV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
Positive result of a urine drug screen at the Screening Visit for opiates, barbiturates, amphetamines, cocaine, benzodiazepines, phencyclidine, and propoxyphene.
History of uncontrolled seizures, cancer (except basal cell carcinoma of the skin), or uncontrolled diabetes, as defined by a hemoglobin A1C level > 8.0% or other systemic diseases that affect directly the CNS and brain metabolites.
Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
Clinical hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
Solid organ transplantation.
Significant pulmonary disease or significant cardiac disease.
Significant drug allergy (such as anaphylaxis or hepatotoxicity).
Contraindications for MRI study
Screening laboratory analyses show any of the following abnormal laboratory results:
Alanine aminotransferase (ALT) > 10 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) > 10 × ULN
Calculated creatinine clearance (using CKD-EPI equal) < 30 mL/min
Albumin < lower limit of normal (LLN)
INR > 1.5
Hemoglobin < LLN
Platelets < 90,000 cells per mm3
Total bilirubin > 2.0 mg/dL
HCV RNA levels that are above the upper level of assay quantification
Screening ECG with clinically significant abnormalities
Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive the study medication
Donation or loss of more than 400 ml blood within 2 months prior to Baseline/Day 1

Trial locations and contacts

1 site in 1 country.

Germany1 site

Hannover Medical School
Hanover, 30625

Other trials in Germany

About this study

Official title: A Monocenter Randomized Double-blind Placebo-controlled Study to Investigate Neuropsychiatric Manifestations of HCV-infection During and After Treatment With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir

This is a 1:1 randomized double-blind Placebo-controlled moncenter Phase IV study to investigate whether a successful interferon-free treatment of HCV-infection with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in combination with dasabuvir (DSV) improves the patients' attention ability as compared to placebo as measured with the Att Test Sum Score change from baseline to week 12. A total of 30 patients with non-cirrhotic genotype 1b HCV infection will be randomly assigned to receive 12 weeks verum followed by 12 weeks Placebo (arm A) versus 12 weeks Placebo followed by 12 weeks verum (arm B). Patients will be followed up for 48 weeks.

Conditions: Hepatitis C, Chronic
Being tested: OBV/PTV/r and DSV, Placebo to match OBV/PTV/r and DSV
Keywords: chronic HCV Genotype 1b infection, HCV RNA, OBV/PTV/r in combination with DSV, neuropsychiatric manifestations
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OBV/PTV/r and DSVDrug
Also called Viekirax and Exviera
OBV/PTV/r (12.5 mg/ 75 mg/ 50 mg) in combination with DSV (250 mg): Two tablets of OBV/PTV/r in the morning and one tablet of DSV in the morning and one tablet of DSV in the evening orally with a meal without regard to fat or calorie content.
Placebo to match OBV/PTV/r and DSVDrug
Placebo to match OBV/PTV/r and DSV

Study groups in NCT03003338
Study group	Role	What they receive
OBV/PTV/r with DSV followed by placebo	Experimental	OBV/PTV/r in combination with DSV for 12 weeks followed by 12 weeks matching placebo. Receives: Drug: OBV/PTV/r and DSV; Drug: Placebo to match OBV/PTV/r and DSV
Placebo followed by OBV/PTV/r with DSV	Experimental	Matching placebo for 12 weeks followed by 12 weeks OBV/PTV/r in combination with DSV. Receives: Drug: OBV/PTV/r and DSV; Drug: Placebo to match OBV/PTV/r and DSV

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Attention Test Battery Sum Score (Att Test Sum Score) at week 12 (12 weeks minus baseline)
To investigate whether a successful interferon-free treatment of HCV-infection with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in combination with dasabuvir (DSV) improves the patients' attention ability as compared to placebo as measured with the Att Test Sum Score change from baseline to week 12.
Measured: 12 weeks

Secondary outcomes (30)

Efficacy of treatment with OBV/PTV/r in combination with DSV for 12w in patients with chronic genotype 1b HCV infection as measured by the proportion of subjects with sustained viral response at FU 12 after discontinuation of therapy
To investigate whether a treatment with OBV/PTV/r in combination with DSV for 12 wk in patients with chronic genotype 1b HCV infection is safe and effective in patients with chronic fatigue and impaired neuropsychiatric function
Measured: Baseline and FU12
Efficacy of treatment with OBV/PTV/r in combination with DSV for 12w in patients with chronic genotype 1b HCV infection as measured by the proportion of subjects with sustained viral response at FU 24 after discontinuation of therapy
To investigate whether a treatment with OBV/PTV/r in combination with DSV for 12 wk in patients with chronic genotype 1b HCV infection is safe and effective in patients with chronic fatigue and impaired neuropsychiatric function
Measured: Baseline and FU 24
Efficacy of treatment with OBV/PTV/r in combination with DSV for 12w in patients with chronic genotype 1b HCV infection as measured by the proportion of subjects with sustained viral response at FU48 after discontinuation of therapy
To investigate whether a treatment with OBV/PTV/r in combination with DSV for 12 wk in patients with chronic genotype 1b HCV infection is safe and effective in patients with chronic fatigue and impaired neuropsychiatric function
Measured: Baseline and FU 48
Change in FIS at Treatment week 12 after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves FIS.
Measured: Baseline and week 12
Change in FIS at Treatment at 12 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves FIS.
Measured: Baseline and 12 weeks of follow-up
Change in FIS at Treatment at 24 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves FIS.
Measured: Baseline and 24 weeks of follow-up
Change in FIS at Treatment at 48 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves FIS.
Measured: Baseline and 48 weeks of follow-up
Change in Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) total score at Treatment week 12 after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) score.
Measured: Baseline and 12 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) total score at 12 weeks follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) score.
Measured: Baseline and 12 weeks follow-up
Change in Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) total score at 24 weeks follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) score.
Measured: Baseline and 24 weeks follow-up
Change in Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) total score at 48 weeks follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) score.
Measured: Baseline and 48 weeks follow-up
Change in TAP Attention test scores at Treatment week 12 after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves TAP Attention test scores.
Measured: Baseline and 12 weeks
Change in TAP Attention test scores at 12 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves TAP Attention test scores.
Measured: Baseline and 12 weeks follow-up
Change in TAP Attention test scores at 24 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves TAP Attention test scores.
Measured: Baseline and 24 weeks follow-up
Change in TAP Attention test scores at 48 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves TAP Attention test scores.
Measured: Baseline and 48 weeks follow-up
Change in word-figure Memory test scores for verbal and figural Memory function at Treatment week 12 after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves word-figure Memory test scores for verbal and figural Memory function.
Measured: Baseline and 12 weeks
Change in word-figure Memory test scores for verbal and figural Memory function at 12 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves word-figure Memory test scores for verbal and figural Memory function.
Measured: Baseline and 12 weeks follow-up
Change in word-figure Memory test scores for verbal and figural Memory function at 24 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves word-figure Memory test scores for verbal and figural Memory function.
Measured: Baseline and 24 weeks follow-up
Change in word-figure Memory test scores for verbal and figural Memory function at 48 weeks of follow-up after Treatment discontinuation
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves word-figure Memory test scores for verbal and figural Memory function.
Measured: Baseline and 48 weeks follow-up
Change in brain metabolite Levels after anti-viral Treatment
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection results in changes of the cerebral metabolites N-acetyl-aspartate, total creatine, choline, Glutamin/Glutamate, and myo-inositol.
Measured: Baseline and 12 weeks
Change in brain metabolite Levels after 12 weeks follow-up
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection results in changes of the cerebral metabolites N-acetyl-aspartate, total creatine, choline, Glutamin/Glutamate, and myo-inositol.
Measured: Baseline and 12 weeks follow-up
Change in brain metabolite Levels after 24 weeks follow-up
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection results in changes of the cerebral metabolites N-acetyl-aspartate, total creatine, choline, Glutamin/Glutamate, and myo-inositol.
Measured: Baseline and 24 weeks follow-up
Change in brain metabolite Levels after 48 weeks follow-up
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection results in changes of the cerebral metabolites N-acetyl-aspartate, total creatine, choline, Glutamin/Glutamate, and myo-inositol.
Measured: Baseline and 48 weeks follow-up
Change in the patients mood at Treatment week 12
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves the patients mood as measured with the Hospital Anxiety and Depression Score.
Measured: Baseline and week 12
Change in the patients mood at 12 weeks follow-up
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves the patients mood as measured with the Hospital Anxiety and Depression Score.
Measured: Baseline and 12 weeks follow-up
Change in the patients mood at 24 weeks follow-up
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves the patients mood as measured with the Hospital Anxiety and Depression Score.
Measured: Baseline and 24 weeks follow-up
Change in the patients mood at 48 weeks follow-up
To investigate whether treatment with OBV/PTV/r in combination with DSV for 12 weeks in patients with chronic genotype 1b HCV infection improves the patients mood as measured with the Hospital Anxiety and Depression Score.
Measured: Baseline and 24 weeks follow-up
Change in the Att Test Sum Score at 12 weeks of follow-up
Measured: Baseline and 12 weeks follow-up
Change in the Att Test Sum Score at 24 weeks of follow-up
Measured: Baseline and 24 weeks follow-up
Change in the Att Test Sum Score at 48 weeks of follow-up
Measured: Baseline and 48 weeks follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201722 Oct 2018

First posted28 Dec 2016 (estimated)
Study start24 Oct 2017
Primary completion22 Oct 2018
Study completion22 Oct 2018

Why it stopped: The recruitment was stopped prematurely by the sponsor in accordance with the principal investigator because of the difficulties to recruit patients and to achieve the planned numbers of patients within a reasonable time frame.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03003338
Sponsor's protocol ID: MHH-HCV-NPM
Other IDs: 2015-004556-22, 2015
Status last verified: Aug 2023
First submitted: 15 Jul 2016
Last updated: 14 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
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Enrolling by invitationObservational study
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All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Monocenter Randomized Double-blind Placebo-controlled Study to Investigate Neuropsychiatric Manifestations of HCV-infection During and After Treatment With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
ClinicalTrials.gov ID: NCT03003338
Acronym / sponsor ID: MHH-HCV-NPM
Conditions: Hepatitis C, Chronic
Keywords: chronic HCV Genotype 1b infection, HCV RNA, OBV/PTV/r in combination with DSV, neuropsychiatric manifestations
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The recruitment was stopped prematurely by the sponsor in accordance with the principal investigator because of the difficulties to recruit patients and to achieve the planned numbers of patients within a reasonable time frame.
Enrolment: 5 participants (actual)
Lead sponsor: Hannover Medical SchoolUniversity, hospital or other
Collaborators: AbbVie
Study start: 24 Oct 2017 (actual)
Primary completion: 22 Oct 2018 (actual)
Study completion: 22 Oct 2018 (actual)
First posted: 28 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
OBV/PTV/r with DSV followed by placebo	Experimental	Drug: OBV/PTV/r and DSV, Drug: Placebo to match OBV/PTV/r and DSVOBV/PTV/r in combination with DSV for 12 weeks followed by 12 weeks matching placebo.
Placebo followed by OBV/PTV/r with DSV	Experimental	Drug: OBV/PTV/r and DSV, Drug: Placebo to match OBV/PTV/r and DSVMatching placebo for 12 weeks followed by 12 weeks OBV/PTV/r in combination with DSV.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (28 listed)

Willing and able to provide written informed consent
Male or female, age ≥18 years
Chronic hepatitis C virus infection
Fatigue Impact Scale Score (FIS) >45 and a sum score (Att Test Sum Score) >0.4 in the battery of attention tests applied.
Female who is:

Key exclusion criteria (30 listed)

Any previous exposure to HCV protease inhibitors, HCV NS5A inhibitors or HCV polymerase inhibitors
History of severe, life threatening or other significant sensitivity to any drug.
Pregnant or nursing female or male with pregnant female partner
Recent (within 6-months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
Infection with hepatitis B virus (HBV; defined as HBsAg-positive) or human immunodeficiency virus (HIV)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OBV/PTV/r and DSVAlso: Viekirax and ExvieraOBV/PTV/r (12.5 mg/ 75 mg/ 50 mg) in combination with DSV (250 mg): Two tablets of OBV/PTV/r in the morning and one tablet of DSV in the morning and one tablet of DSV in the evening orally with a meal without regard to fat or calorie content.	Drug	OBV/PTV/r with DSV followed by placebo, Placebo followed by OBV/PTV/r with DSV
Placebo to match OBV/PTV/r and DSVPlacebo to match OBV/PTV/r and DSV	Drug	OBV/PTV/r with DSV followed by placebo, Placebo followed by OBV/PTV/r with DSV

Primary outcome

Change in the Attention Test Battery Sum Score (Att Test Sum Score) at week 12 (12 weeks minus baseline)
Time frame: 12 weeks
To investigate whether a successful interferon-free treatment of HCV-infection with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in combination with dasabuvir (DSV) improves the patients' attention ability as compared to placebo as measured with the Att Test Sum Score change from baseline to week 12.

30 secondary outcomes

Efficacy of treatment with OBV/PTV/r in combination with DSV for 12w in patients with chronic genotype 1b HCV infection as measured by the proportion of subjects with sustained viral response at FU 12 after discontinuation of therapy
Time frame: Baseline and FU12
Efficacy of treatment with OBV/PTV/r in combination with DSV for 12w in patients with chronic genotype 1b HCV infection as measured by the proportion of subjects with sustained viral response at FU 24 after discontinuation of therapy
Time frame: Baseline and FU 24
Efficacy of treatment with OBV/PTV/r in combination with DSV for 12w in patients with chronic genotype 1b HCV infection as measured by the proportion of subjects with sustained viral response at FU48 after discontinuation of therapy
Time frame: Baseline and FU 48
Change in FIS at Treatment week 12 after Treatment discontinuation
Time frame: Baseline and week 12
Change in FIS at Treatment at 12 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 12 weeks of follow-up
Change in FIS at Treatment at 24 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 24 weeks of follow-up
Change in FIS at Treatment at 48 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 48 weeks of follow-up
Change in Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) total score at Treatment week 12 after Treatment discontinuation
Time frame: Baseline and 12 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) total score at 12 weeks follow-up after Treatment discontinuation
Time frame: Baseline and 12 weeks follow-up
Change in Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) total score at 24 weeks follow-up after Treatment discontinuation
Time frame: Baseline and 24 weeks follow-up
Change in Repeatable Battery for the Assessment of Neuropsychological Function (RBANS) total score at 48 weeks follow-up after Treatment discontinuation
Time frame: Baseline and 48 weeks follow-up
Change in TAP Attention test scores at Treatment week 12 after Treatment discontinuation
Time frame: Baseline and 12 weeks
Change in TAP Attention test scores at 12 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 12 weeks follow-up
Change in TAP Attention test scores at 24 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 24 weeks follow-up
Change in TAP Attention test scores at 48 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 48 weeks follow-up
Change in word-figure Memory test scores for verbal and figural Memory function at Treatment week 12 after Treatment discontinuation
Time frame: Baseline and 12 weeks
Change in word-figure Memory test scores for verbal and figural Memory function at 12 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 12 weeks follow-up
Change in word-figure Memory test scores for verbal and figural Memory function at 24 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 24 weeks follow-up
Change in word-figure Memory test scores for verbal and figural Memory function at 48 weeks of follow-up after Treatment discontinuation
Time frame: Baseline and 48 weeks follow-up
Change in brain metabolite Levels after anti-viral Treatment
Time frame: Baseline and 12 weeks
Change in brain metabolite Levels after 12 weeks follow-up
Time frame: Baseline and 12 weeks follow-up
Change in brain metabolite Levels after 24 weeks follow-up
Time frame: Baseline and 24 weeks follow-up
Change in brain metabolite Levels after 48 weeks follow-up
Time frame: Baseline and 48 weeks follow-up
Change in the patients mood at Treatment week 12
Time frame: Baseline and week 12
Change in the patients mood at 12 weeks follow-up
Time frame: Baseline and 12 weeks follow-up
Change in the patients mood at 24 weeks follow-up
Time frame: Baseline and 24 weeks follow-up
Change in the patients mood at 48 weeks follow-up
Time frame: Baseline and 24 weeks follow-up
Change in the Att Test Sum Score at 12 weeks of follow-up
Time frame: Baseline and 12 weeks follow-up
Change in the Att Test Sum Score at 24 weeks of follow-up
Time frame: Baseline and 24 weeks follow-up
Change in the Att Test Sum Score at 48 weeks of follow-up
Time frame: Baseline and 48 weeks follow-up

Results and safety

The study was stopped early (reason given: The recruitment was stopped prematurely by the sponsor in accordance with the principal investigator because of the difficulties to recruit patients and to achieve the planned numbers of patients within a reasonable time frame.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heiner Wedemeyer, Prof. Dr. principal investigator

Hannover Medical School, Department of Gastroenterology, Hepatology and Endocrinology, Carl-Neuberg-Str. 1, 30625 Hannover, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OBV/PTV/r and DSV in people with Hepatitis C, Chronic, run by Hannover Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Attention Test Battery Sum Score (Att Test Sum Score) at week 12 (12 weeks minus baseline) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03003338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.