Hepatitis C Virus (HCV)Phase 3EXPEDITION-5NCT03069365
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment
A Phase 3 study testing Glecaprevir/pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 38 sites in 10 countries.
Trial summary
This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus (HCV)
- What is being tested?
- Glecaprevir/pibrentasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 38 sitesin 10 countries
- Study dates
- 28 Mar 2017to 5 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female (of non-childbearing potential or using allowed contraceptive methods) at least 18 years of age time of Screening
- Participant had a positive anti-hepatitis C virus (HCV) antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at the Screening Visit.
- Participant had an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method at Screening according to the following formula: eGFR (mL/min/1.73 m^2 ) = 175 × (Serum Creatinine) ^-1.154 × Age^-0.203 × (0.742 if female) × (1.212 if black), or were dialysis dependent. Subjects requiring dialysis had to have been receiving dialysis for at least 1 month prior to enrollment, and may have been on hemodialysis or peritoneal dialysis.
- Cirrhotic participants only: absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Participants who had an ultrasound with results suspicious of HCC followed by a subsequent negative CT or MRI of the liver were eligible for the study.
Who cannot join
- Female participants who were pregnant, breastfeeding, or were considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug
- Current hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection on screening tests, defined as:
- Positive test result at Screening for hepatitis B surface antigen (HBsAg), or;
- HBV deoxyribonucleic acid (DNA) greater than lower limit of quantification (LLOQ) in participants with isolated positive hepatitis B core antibody (HBcAb), (i.e., negative HBsAg and Anti-HBsAg), or;
- Positive anti-HIV antibody (Ab).
- Any current or historical clinical evidence of decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy or variceal bleeding; radiographic evidence of small ascites; or prior or current empiric use of lactulose/rifaximin for neurologic indications. Prophylactic use of beta blockers was not exclusionary.
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- Clinical history of acute renal failure in the 3 months prior to Screening
- History of severe, life-threatening, or other significant sensitivity to any excipients of the study drugs
- Clinically significant abnormalities or co-morbidities, or recent (within 6 months prior to study drug administration) alcohol or drug abuse that could preclude adherence to the protocol in the opinion of the investigator
- Receipt of any investigational or commercially available direct acting anti-HCV agents other than sofosbuvir
Trial locations and contacts
38 sites in 10 countries.
38 sites in 10 countries
United States11 sites
Massachusetts General Hospital /ID# 159114
Boston, Massachusetts, 02114
Carolinas Medical Center /ID# 159113
Charlotte, North Carolina, 28203
Scripps Clinic /ID# 159116
La Jolla, California, 92037
North Shore University Hospital /ID# 159108
New Hyde Park, New York, 11040
Columbia Univ Medical Center /ID# 159112
New York, New York, 10032-3725
Huntington Medical Foundation /ID# 160653
Pasadena, California, 91105
University of Pennsylvania /ID# 159117
Philadelphia, Pennsylvania, 19104-5502
Thomas Jefferson University /ID# 159754
Philadelphia, Pennsylvania, 19107-4414
TX Liver Inst, Americ Res Corp /ID# 159111
San Antonio, Texas, 78215
Northwest Louisiana Nephrology /ID# 160652
Shreveport, Louisiana, 71101
Tampa General Medical Group /ID# 159115
Tampa, Florida, 33606
Canada4 sites
Zeidler Ledcor Centre /ID# 160600
Edmonton, Alberta, T6G 2X8
Toronto General Hospital /ID# 160601
Toronto, Ontario, M5G 2C4
Vancouver ID Research and Care /ID# 160598
Vancouver, British Columbia, V6Z 2C7
GIRI Gastrointestinal Research Institute /ID# 160599
Vancouver, British Columbia, V6Z 2K5
Germany4 sites
Universitätsklinikum Frankfurt /ID# 160826
Frankfurt am Main, Hesse, 60590
Med Hochschule Hanover /ID# 160827
Hanover, 30625
Univ Johannes Gutenberg /ID# 160828
Mainz, 55131
Universitatsklinikum Mannheim /ID# 160829
Mannheim, Baden-Wurttemberg, 68167
Greece4 sites
Gen Univ Hosp Alexandroupolis /ID# 160724
Alexandroupoli, 68100
General Hospital of Athens Laiko /ID# 160725
Athens, Attica, 115 27
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 160726
Athens, 10676
Bioclinic Thessaloniki /ID# 160723
Thessaloniki, 54622
Italy4 sites
A.O.U. Policlinico S.Orsola-Malpighi /ID# 163349
Bologna, Emilia-Romagna, 40138
Policlinico Paolo Giaccone /Id# 160718
Palermo, Sicily, 90127
Policlinico A. Gemelli /ID# 160719
Rome, Lazio, 00168
A.O. Uni Giovanni e Ruggi /ID# 160720
Salerno, 84100
South Korea3 sites
Hanyang University Seoul Hospi /ID# 160259
Seongdong, Seoul Teugbyeolsi, 04763
Severance Hospital /ID# 160261
Seoul, Seoul Teugbyeolsi, 03722
Asan Medical Center /ID# 160260
Seoul, 05505
Spain3 sites
Hospital Parc de Salut del Mar /ID# 159975
Barcelona, 08003
Hospital Universitario Doce de /ID# 159974
Madrid, 28041
Hospital Regional de Malaga /ID# 159976
Málaga, Malaga, 29009
Poland2 sites
Uniwersytecki Szpital Kliniczn /ID# 161081
Bialystok, 15-276
HepID - Diagnostyka I Terapia /ID# 161083
Lublin, Lublin Voivodeship, 20-884
Puerto Rico2 sites
VA Caribbean Healthcare System /ID# 160754
San Juan, 00921-3201
School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 160755
San Juan, 00935
About this study
Official title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-5)
This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.
Read the detailed description
The study included a 42-day screening period, a treatment period of either 8, 12, or 16 weeks, and a 24-week post-treatment period. The duration of treatment was determined by product labeling. Participants received glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg once daily. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to monitor safety, hepatitis C virus ribonucleic acid (HCV RNA), and the emergence and persistence of viral substitutions.
- Conditions
- Hepatitis C Virus (HCV)
- Being tested
- Glecaprevir/pibrentasvir
- Keywords
- Chronic Hepatitis C Virus, Chronic Kidney Disease, Glecaprevir, Pibrentasvir, Hepatitis C Virus Genotype, Compensated cirrhosis, Non-cirrhotic, Interferon (IFN), Treatment naïve, Sofosbuvir (SOF), Pegylated interferon (pegIFN), Ribavirin (RBV)
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir/pibrentasvirDrug
Also called ABT-493/ABT-530, MAVYRET
Film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| GLE/PIB for 8 weeks | Experimental | HCV genotype 1,2,4-6 non-cirrhotic, treatment-naive or treatment-experienced; genotype 3 non-cirrhotic, treatment-naïve participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 8 weeks Receives: Drug: Glecaprevir/pibrentasvir |
| GLE/PIB for 12 weeks | Experimental | HCV genotype 1,2,4-6 compensated cirrhosis, treatment-naive or treatment-experienced; genotype 3 compensated cirrhosis, treatment- naïve participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 12 weeks Receives: Drug: Glecaprevir/pibrentasvir |
| GLE/PIB for 16 weeks | Experimental | HCV genotype 3 non-cirrhotic or with compensated cirrhosis, treatment-experienced participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 16 weeks Receives: Drug: Glecaprevir/pibrentasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Measured: 12 weeks after the last actual dose of study drug
Secondary outcomes (2)
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as:
- Confirmed increase from nadir in hepatitis C virus ribonucleic acid (HCV RNA) defined as confirmed increase of > 1 log (subscript)10(subscript) IU/mL above nadir during treatment; or
- Confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA less than the lower limit of quantification (LLOQ) during study drug treatment; or
- HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment
Measured: Up to 16 weeks
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be reinfected were not considered to have relapsed.
.
Measured: Up to 12 weeks after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start28 Mar 2017
- Primary completion20 Feb 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069365
- Sponsor's protocol ID
- M16-127
- Other IDs
- 2016-004182-60, 2016
- Acronym
- EXPEDITION-5
- Status last verified
- Jan 2019
- First submitted
- 28 Feb 2017
- Last updated
- 4 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
- Expanded access
- Available
Publications
Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.
PubMed 35174470Lawitz E, Flisiak R, Abunimeh M, Sise ME, Park JY, Kaskas M, Bruchfeld A, Worns MA, Aglitti A, Zamor PJ, Xue Z, Schnell G, Jalundhwala YJ, Porcalla A, Mensa FJ, Persico M. Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection. Liver Int. 2020 May;40(5):1032-1041. doi: 10.1111/liv.14320. Epub 2019 Dec 26.
PubMed 31821716
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-5)
- ClinicalTrials.gov ID
- NCT03069365
- Acronym / sponsor ID
- EXPEDITION-5 / M16-127
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- Chronic Hepatitis C Virus, Chronic Kidney Disease, Glecaprevir, Pibrentasvir, Hepatitis C Virus Genotype, Compensated cirrhosis, Non-cirrhotic, Interferon (IFN)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Posted 4 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.
Detailed description
The study included a 42-day screening period, a treatment period of either 8, 12, or 16 weeks, and a 24-week post-treatment period. The duration of treatment was determined by product labeling. Participants received glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg once daily. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to monitor safety, hepatitis C virus ribonucleic acid (HCV RNA), and the emergence and persistence of viral substitutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLE/PIB for 8 weeks | Experimental | Drug: Glecaprevir/pibrentasvirHCV genotype 1,2,4-6 non-cirrhotic, treatment-naive or treatment-experienced; genotype 3 non-cirrhotic, treatment-naïve participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 8 weeks |
| GLE/PIB for 12 weeks | Experimental | Drug: Glecaprevir/pibrentasvirHCV genotype 1,2,4-6 compensated cirrhosis, treatment-naive or treatment-experienced; genotype 3 compensated cirrhosis, treatment- naïve participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 12 weeks |
| GLE/PIB for 16 weeks | Experimental | Drug: Glecaprevir/pibrentasvirHCV genotype 3 non-cirrhotic or with compensated cirrhosis, treatment-experienced participants treated with glecaprevir/pibrentasvir (GLE/PIB): three 100 mg/40 mg co-formulated tablets once daily with food for 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female (of non-childbearing potential or using allowed contraceptive methods) at least 18 years of age time of Screening
- Participant had a positive anti-hepatitis C virus (HCV) antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at the Screening Visit.
- Participant had an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method at Screening according to the following formula: eGFR (mL/min/1.73 m^2 ) = 175 × (Serum Creatinine) ^-1.154 × Age^-0.203 × (0.742 if female) × (1.212 if black), or were dialysis dependent. Subjects requiring dialysis had to have been receiving dialysis for at least 1 month prior to enrollment, and may have been on hemodialysis or peritoneal dialysis.
- Cirrhotic participants only: absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Participants who had an ultrasound with results suspicious of HCC followed by a subsequent negative CT or MRI of the liver were eligible for the study.
Key exclusion criteria (10 listed)
- Female participants who were pregnant, breastfeeding, or were considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug
- Current hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection on screening tests, defined as:
- Positive test result at Screening for hepatitis B surface antigen (HBsAg), or;
- HBV deoxyribonucleic acid (DNA) greater than lower limit of quantification (LLOQ) in participants with isolated positive hepatitis B core antibody (HBcAb), (i.e., negative HBsAg and Anti-HBsAg), or;
- Positive anti-HIV antibody (Ab).
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 |
|---|---|---|
| Glecaprevir/pibrentasvirAlso: ABT-493/ABT-530, MAVYRETFilm-coated tablet | Drug | GLE/PIB for 12 weeks, GLE/PIB for 16 weeks, GLE/PIB for 8 weeks |
Primary outcome
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12)
Time frame: 12 weeks after the last actual dose of study drug
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
2 secondary outcomes
Percentage of Participants With On-treatment Virologic Failure
Time frame: Up to 16 weeks
Percentage of Participants With Post-treatment Relapse
Time frame: Up to 12 weeks after the last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35174470Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.
- Derived from this study: PubMed 31821716Lawitz E, Flisiak R, Abunimeh M, Sise ME, Park JY, Kaskas M, Bruchfeld A, Worns MA, Aglitti A, Zamor PJ, Xue Z, Schnell G, Jalundhwala YJ, Porcalla A, Mensa FJ, Persico M. Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection. Liver Int. 2020 May;40(5):1032-1041. doi: 10.1111/liv.14320. Epub 2019 Dec 26.
- Individual participant dataSharing planned: Undecided
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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.
AbbVie Inc. study director
AbbVie
38 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glecaprevir/pibrentasvir in people with Hepatitis C Virus (HCV), run by AbbVie at 38 sites in 10 countries.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada, Germany, Greece, Italy and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12) (time frame: 12 weeks after the last actual dose of study drug). 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 NCT03069365, which also lists 2 linked publications.
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 4 Mar 2019.