Hepatitis CPhase 1NCT03253471
A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection
A Phase 1 study testing AL-611 in people with Hepatitis C, run by Alios Biopharma Inc. at 1 site in Belgium.
Trial summary
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- AL-611
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Jul 2017to 18 Sep 2017
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has provided written consent.
- In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
- Except in compensated cirrhosis (cirrhosis cohorts only) and diagnosis of HCV (Part 3 only), subject is in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Male or female, 18-60 years of age for HV and 18-70 years of age for subjects with CHC.
- Body mass index (BMI) 18-30 kg/m2, inclusive, for HV and 18-35 kg/m^2, inclusive, for subjects with CHC. The minimum weight is 50 kg in both populations.
- A female subject is eligible to participate in this study if she is of non-childbearing potential (defined as females with a documented tubal ligation, bilateral oophorectomy, or hysterectomy) or postmenopausal (defined as 12 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females).
Show all 14Show fewer
- If male, subject is surgically sterile or practicing specific forms of birth control until 6 months after the end of the study. Male subjects must agree to refrain from sperm donation from start of dosing through 6 months after the completion of study drug administration.
- Subject agrees to refrain from blood donation from screening until 56 days after the last study visit.
- For HV, estimated glomerular filtration rate (eGFR) in the normal range as determined by modification of diet in renal disease (MDRD) formula. For CHC (Part 3) eGFR>60ml/min/1.73m^2 as determined by MDRD (alternative calculations (eg, Cockroft-Gault) may be permissible, if approved by the Sponsor).
- Additional inclusion criteria for subjects with CHC infection (Part 3):
- Subjects must have GT1 or GT3 CHC (or GT1-6 for Part 3 optional cohorts) infection identified at screening.
- Documentation of HCV infection for greater than 6 months before randomization as defined by either documented HCV serology demonstrating the presence of anti-HCV antibodies at least 6 months before randomization or documented presence of HCV RNA at least 6 months before randomization.
- Screening HCV RNA viral load ≥50,000 IU/mL (except for subjects with compensated cirrhosis, who may have HCV RNA viral load ≥10^4 IU/mL) using Ampliprep COBAS® Taqman® HCV Test 2.0
- Cirrhotic subjects in Part 3 must have compensated cirrhosis AND meet the Child-Pugh Class A definition AND have a screening Fibroscan with a liver stiffness score>12.5 kPa.
Who cannot join
- History or other clinical evidence of significant or unstable cardiac disease (eg, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia (eg, long QT syndrome, torsades de pointes), coronary heart disease), moderate to severe valvular disease or poorly controlled hypertension at screening.
- Family history of prolonged QT syndrome (eg, torsade de pointes) or sudden cardiac death.
- Clinically significant abnormal screening ECG findings (eg, PR >220 msec, QRS interval >120 msec or corrected QT interval (QTcF) >450 msec for male subjects and >470 msec for female subjects).
- Participation in either an investigational drug trial or an investigational vaccine trial within 30 days or 5 half lives (whichever is longer) prior to starting study medication.
- Clinically significant blood loss or elective blood donation of significant volume (ie, >500 mL) within 60 days prior to screening; >1 unit of plasma within 7 days prior to screening.
- Unwilling to abstain from alcohol for 48 hours prior to the start of dosing through the study completion visit.
Show all 23Show fewer
- History of regular alcohol intake >14 units per week of alcohol for females and >21 units per week for males (one unit is defined as 10 g alcohol) within 3 months of randomization
- The subject has a positive alcohol test at screening or on Day -2.
- Hypersensitivity to the active substance or to any of the excipients of AL-611
- Abnormal (using local normal range) heart rate, respiratory rate, temperature or blood pressure (BP) values (evaluated in a semi-recumbent or recumbent position after 5 minutes of rest). One repeat measurement after an additional ~5 minutes of rest is permitted. In addition, a repeat measurement performed on a separate day is also permitted.
- Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hepatic, hematologic, neurologic, oncologic (except adequately treated basal cell carcinoma and cervical intraepithelial neoplasia [CIN] I or II), autoimmune, or any other medical illness or psychiatric disorder, as determined by the Investigator. CHC with/without compensated cirrhosis acceptable for cohorts enrolling CHC subjects with/without compensated cirrhosis, respectively, but non-HCV related hepatic disease is exclusionary.
- Positive test for hepatitis A virus (HAV) IgM, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody. For HV HCV is exclusionary.
- Evidence of active infection (topical fungal infections which are considered not clinically significant are permitted). CHC is inclusionary for Part 3 only.
- History of regular use of tobacco (ie, ≥10 cigarettes per day or equivalent for alternative nicotine products (eg, e cigarettes)) within 3 months of randomization.
- The subject has a positive drug screen during screening or on Day -2. For CHC, prescribed medications with a stable dose for at least 21 days may be considered by the Investigator and Sponsor Medical Monitor; cannabis is permitted.
- From 14 days (or 5 half-lives, whichever is longer) prior to admission to the Phase 1 Unit until randomization, use of any medications, including prescription, over the counter, and herbal medications, is exclusionary. The only exceptions are acetaminophen, ibuprofen, hormone replacement therapy, and thyroid hormone replacement therapy.
- Abnormal screening laboratory results that are considered clinically significant by the investigator or as specified in the protocol.
- Additional exclusion criteria for subjects with CHC (Part 3):
- History of clinical hepatic decompensation, eg, variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy or active jaundice (within the last year).
- Except subjects with compensated cirrhosis, a liver biopsy within 2 years that demonstrates cirrhosis (Knodell score >3, Metavir score >3, Ishak score >4) or a screening Fibroscan liver stiffness score >12.5 kPa.
- Prior treatment for CHC, defined as prior exposure to any approved or investigational drugs intended to treat HCV infection. In subjects with compensated cirrhosis, prior relapse after a complete course of, or premature discontinuation from, interferon-based treatment regimens (±ribavirin) is acceptable, but prior exposure to any direct-acting antivirals (DAAs) is exclusionary.
- Evidence on screening liver ultrasound of hepatic mass or lesion concerning for malignancy (subjects with cirrhosis only).
- For CHC subjects without cirrhosis, alpha fetoprotein (AFP) concentrations ≤ upper limit of normal (ULN). If AFP is >ULN, absence of a hepatic mass or lesion must be demonstrated by ultrasound within the screening period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-611 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part 3) of Single Ascending Doses in Healthy Volunteers (Parts 1-2), and Multiple Ascending Doses in Subjects With Chronic Hepatitis C Virus Infection (Part 3)
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3).
Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)
- Conditions
- Hepatitis C
- Being tested
- AL-611, Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-611Drug
AL-611 tablets
PlaceboDrug
Placebo to Match AL-611
| Study group | Role | What they receive |
|---|---|---|
| AL-611 | Experimental | Not described Receives: Drug: AL-611 |
| Placebo to Match AL-611 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment emergent Adverse events
Measured: Up to 21 days
Physical examination findings
Measured: Up to 21 days
Incidence and severity of vital sign abnormalities
Measured: Up to 21 days
Incidence and severity of 12 lead electrocardiagram abnormalities
Measured: Up to 21 days
Incidence and severity of clinical laboratory abnormalities
Measured: Up to 21 days
Secondary outcomes (20)
Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
C0_h of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Measured: Day 1 to Day 21
Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose
Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose in HV in fasted conditions
Measured: Day 1 to Day 8
HCV RNA viral load in subjects with CHC
HCV RNA viral load (over time, maximum decrease from baseline, and change from baseline over time) in subjects with CHC, defined by GT and host characteristic (eg, presence/absence of compensated cirrhosis)
Measured: Screening to Day 21
Sequence analysis of HCV
Measured: Day 1 to Day 21
tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
C24h of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
Clast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
tlast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
CL/F of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
Vz/F of AL-611 following single dose administration
PK parameter of AL-611 following single dose administration
Measured: Day 1 to Day 8
AUC0-inf of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Measured: Day 1 to Day 8
Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Measured: Day 1 to Day 21
tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Measured: Day 1 to Day 21
Cmin of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Measured: Day 1 to Day 21
t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Measured: Day 1 to Day 21
AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Measured: Day 1 to Day 21
AUC0_tau of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Measured: Day 1 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start7 Jul 2017
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
Why it stopped: Strategic decision to discontinue further development of investigational compounds for the treatment of hepatitis C.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alios Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mina Pastagia, Study director, Alios Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253471
- Sponsor's protocol ID
- AL-611-1101
- Status last verified
- Oct 2017
- First submitted
- 2 Aug 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Corneillie L, Meziere L, Montpellier C, Drouet B, Aliouat-Denis CM, Cocquerel L. Update on the molecular and cellular biology of hepatitis E virus and therapeutic opportunities. Antiviral Res. 2026 Mar;247:106353. doi: 10.1016/j.antiviral.2026.106353. Epub 2026 Jan 20.
PubMed 41571028
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-611 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part 3) of Single Ascending Doses in Healthy Volunteers (Parts 1-2), and Multiple Ascending Doses in Subjects With Chronic Hepatitis C Virus Infection (Part 3)
- ClinicalTrials.gov ID
- NCT03253471
- Acronym / sponsor ID
- AL-611-1101
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision to discontinue further development of investigational compounds for the treatment of hepatitis C.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alios Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- 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.
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3).
Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL-611 | Experimental | Drug: AL-611 |
| Placebo to Match AL-611 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject has provided written consent.
- In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
- Except in compensated cirrhosis (cirrhosis cohorts only) and diagnosis of HCV (Part 3 only), subject is in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Male or female, 18-60 years of age for HV and 18-70 years of age for subjects with CHC.
- Body mass index (BMI) 18-30 kg/m2, inclusive, for HV and 18-35 kg/m^2, inclusive, for subjects with CHC. The minimum weight is 50 kg in both populations.
Key exclusion criteria (23 listed)
- History or other clinical evidence of significant or unstable cardiac disease (eg, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia (eg, long QT syndrome, torsades de pointes), coronary heart disease), moderate to severe valvular disease or poorly controlled hypertension at screening.
- Family history of prolonged QT syndrome (eg, torsade de pointes) or sudden cardiac death.
- Clinically significant abnormal screening ECG findings (eg, PR >220 msec, QRS interval >120 msec or corrected QT interval (QTcF) >450 msec for male subjects and >470 msec for female subjects).
- Participation in either an investigational drug trial or an investigational vaccine trial within 30 days or 5 half lives (whichever is longer) prior to starting study medication.
- Clinically significant blood loss or elective blood donation of significant volume (ie, >500 mL) within 60 days prior to screening; >1 unit of plasma within 7 days prior to screening.
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 |
|---|---|---|
| AL-611AL-611 tablets | Drug | AL-611 |
| PlaceboPlacebo to Match AL-611 | Drug | Placebo to Match AL-611 |
Primary outcome
Incidence and severity of Treatment emergent Adverse events
Time frame: Up to 21 days
Physical examination findings
Time frame: Up to 21 days
Incidence and severity of vital sign abnormalities
Time frame: Up to 21 days
Incidence and severity of 12 lead electrocardiagram abnormalities
Time frame: Up to 21 days
Incidence and severity of clinical laboratory abnormalities
Time frame: Up to 21 days
20 secondary outcomes
Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
C0_h of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose
Time frame: Day 1 to Day 8
HCV RNA viral load in subjects with CHC
Time frame: Screening to Day 21
Sequence analysis of HCV
Time frame: Day 1 to Day 21
tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
C24h of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
Clast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
tlast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
CL/F of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
Vz/F of AL-611 following single dose administration
Time frame: Day 1 to Day 8
AUC0-inf of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
Cmin of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
AUC0_tau of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
Results and safety
The study was stopped early (reason given: Strategic decision to discontinue further development of investigational compounds for the treatment of hepatitis C.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Derived from this study: PubMed 41571028Corneillie L, Meziere L, Montpellier C, Drouet B, Aliouat-Denis CM, Cocquerel L. Update on the molecular and cellular biology of hepatitis E virus and therapeutic opportunities. Antiviral Res. 2026 Mar;247:106353. doi: 10.1016/j.antiviral.2026.106353. Epub 2026 Jan 20.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Mina Pastagia study director
Alios Biopharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AL-611 in people with Hepatitis C, run by Alios Biopharma Inc. at 1 site in Belgium.
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 14 inclusion and 23 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 25 Oct 2017. 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 Belgium. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic decision to discontinue further development of investigational compounds for the treatment of hepatitis C.). Results are not available in the source record.
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?
Incidence and severity of Treatment emergent Adverse events (time frame: Up to 21 days). The study lists 5 primary outcomes in all. 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 NCT03253471, which also lists 1 linked publication.
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 25 Oct 2017.