Hepatitis C, ChronicPhase 1NCT01081158
Safety, Tolerability, PK and PD of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With HCV Genotype 1 (Protocol No. P04695)
A Phase 1 study testing Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron), Drug: SCH 900518 Biologic: Peginterferon alfa-2b and Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1 (Protocol No. P04695) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron), Drug: SCH 900518 Biologic: Peginterferon alfa-2b and Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Aug 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject infected with HCV genotype 1 (any sub-type) virus who is:
- treatment naïve (eg. to interferon and ribavirin); or
- treatment experienced (non-responder and relapser): subject who received interferon based therapy and continued to have detectable HCV RNA levels at the end of follow-up, a subject who did not attain a 2 log decline in HCV RNA levels at ~12 weeks and discontinued treatment, or subject who had no detectable viral load while on treatment but had a detectable viral load post treatment.
- Subject with acceptable medical history, physical examination, and clinical laboratory evaluations consistent with CHC, compensated liver disease, and any associated diseases (diabetes, hypertension, etc).
- Subjects with an HCV RNA viral load of >10^5 copies/mL or equivalent international units
- BMI of 18 to 40 kg/m^2, men and women, ages 18-65 years inclusive
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- Female must be non-lactating and have a negative pregnancy test at Screening and Day -1 and either be of nonchildbearing potential or if of childbearing potential, must be practicing effective double-barrier contraceptive methods from at least 2 weeks prior to Day -1 until 30 days after study completion.
- Male must be willing to practice barrier contraception from Day 1 through 3 months following treatment with SCH 900518.
- Subject must have an ECG recording showing no clinically significant findings at Screening.
- Subject with chronic stable hemophilia may enroll
- Subject on stable methadone treatment may enroll in this study (evaluation by investigator includes history of stable clinical management for >3 months).
Who cannot join
- Subject has a significant acute or chronic medical illness which is not stable or is not controlled with medication (excluding prohibited medications).
- Subject has received an organ transplant.
- Subject has evidence of decompensated liver disease by physical exam (encephalopathy, ascites, caput medusae, etc).
- Subject has at anytime received an HCV NS3-specific protease inhibitor.
- Subject has a platelet count <80,000/mm^3 (confirmed by repeat analysis) at Screening.
- Subject has a serum hemoglobin of <10.0 g/dL (confirmed by repeat analysis) at Screening.
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- Subject has a serum AST /ALT value >5 x ULN (confirmed by repeat analysis) at Screening.
- Subject has a serum alkaline phosphatase value >2 x ULN (confirmed by repeat analysis) at Screening.
- Two or more of the following criteria (confirmed by repeat analysis) at Screening:
- Total serum bilirubin >2.0 mg/dL.
- Serum albumin <3.5 g/dL.
- INR >1.7 (with the exception of hemophiliacs).
- Subject has a neutrophil count <1,000/mm^3 (confirmed by repeat analysis) at Screening.
- Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 50 mL/min at Screening.
- Subject who has a history of any clinically significant local or systemic infectious disease within 1 week prior to screening (other than HCV-infection).
- Male subject whose female partner intends on becoming pregnant within 3 months of the study.
- Subject is positive for HIV antibodies or hepatitis B surface antigen.
- Subject has a clinically significant allergy or intolerance to foods or drugs, or is known or suspected to have hypersensitivity to any ingredient in the investigational product.
- Subject has a clinically significant history of auto-immune hepatitis.
- Subject has used any investigational drugs or donated blood within 30 days prior to study drug administration.
- Subject who received any of the following treatments: known inhibitor of CYP3A4 metabolism (2 weeks of prior to randomization), known inducer of CYP3A4 metabolism (2 weeks prior to randomization) and treatment for HCV infection (1 month prior to randomization)
About this study
Official title: Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1 (Protocol No. P04695)
Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1 (Protocol No. P04695)
- Conditions
- Hepatitis C, Chronic
- Being tested
- Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron), Drug: SCH 900518 Biologic: Peginterferon alfa-2b, Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron), Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)
- 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.
Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron)Drug
Also called narlaprevir, PegIntron
Drug: SCH 900518
Biologic: Peginterferon alfa-2b(PegIntron)
Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days .
Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly.
Drug: SCH 900518 Biologic: Peginterferon alfa-2bDrug
Also called narlaprevir, PegIntron
Drug: SCH 900518
Biologic: Peginterferon alfa-2b
Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days
Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly.
Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)Drug
Also called narlaprevir, norvir, PegIntron
Drug: SCH 900518
Drug: Ritonavir (RTV)
Biologic: Peginterferon alfa-2b (PegIntron)
Period 1: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension + ritonavir (200 mg BID) (2-100 mg oral capsules) for 7 days.
Period 2: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension+ ritonavir (200 mg BID) (2-100 mg oral capsules) + PegIntron (1.5 µg/kg QW) for 14 days.
Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)Drug
Also called narlaprevir, norvir, PegIntron
Drug: SCH 900518
Drug: Ritonavir (RTV)
Biologic: Peginterferon alfa-2b (PegIntron)
Period 1, Amorphous SCH 900518 (400 mg) or placebo BID administered as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) for 7 days.
Period 2, SCH 900518 (400 mg) or placebo BID as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) +PegIntron (1.5 µg/kg SC QW) for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naïve 800 mg TID | Experimental | Period 1: SCH 900518 (800 mg TID) or placebo for 7 days
Period 2: SCH 900518 (800 mg TID) + PegIntron (1.5 µg/kg QW) or placebo + PegIntron for 14 days. Receives: Drug: Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron) |
| Treatment-experienced: 800 mg TID | Experimental | Period 1: SCH 900518 (800 mg TID) or placebo for 7 days
Period 2: SCH 900518 (800 mg TID) + PegIntron (1.5 ug/kg QW) or placebo + PegIntron for 14 days Receives: Drug: Drug: SCH 900518 Biologic: Peginterferon alfa-2b |
| Treatment-naïve: 400 mg + RTV BID | Experimental | Period 1: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) for 7 days.
Period 2: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) +PegIntron (1.5 µg/kg QW) for 14 days. Receives: Drug: Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron) |
| Treatment-experienced: 400 mg + RTV BID | Experimental | Period 1: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) for 7 days.
Period 2: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) +PegIntron (1.5 µg/kg QW) for 14 days. Receives: Drug: Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability were to be assessed by collecting adverse events (AEs), vital signs, electrocardiograms (ECGs), physical examinations, urinalysis, and safety laboratory tests.
Measured: Screening Period: 90 days, Period 1: 7 days, Washout: 4 weeks, Period 2: 14 days, Standard of Care with PegIntron and ribavirin: 84 days
Secondary outcomes (1)
Log change in HCV-RNA from baseline. Ctrough of SCH 900518 resulting in mean HCV RNA decrease > 2 log10 IU/mL. Ctrough of SCH 900518+PEG resulting in HCV-RNA < LOQ. SCH 900518 PK: Cmax, Tmax, AUC, Ctrough, t½, R, CL/F, Vd/F. PEG and RTV: Ctrough
Measured: Period 1: 7 days, Washout: 4 weeks, Period 2: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081158
- Sponsor's protocol ID
- P04695
- Status last verified
- Feb 2015
- First submitted
- 3 Mar 2010
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
de Bruijne J, Bergmann JF, Reesink HW, Weegink CJ, Molenkamp R, Schinkel J, Tong X, Li J, Treitel MA, Hughes EA, van Lier JJ, van Vliet AA, Janssen HL, de Knegt RJ. Antiviral activity of narlaprevir combined with ritonavir and pegylated interferon in chronic hepatitis C patients. Hepatology. 2010 Nov;52(5):1590-9. doi: 10.1002/hep.23899.
PubMed 20938912Hotho DM, de Bruijne J, Spaan M, Treitel MA, Boonstra A, de Knegt RJ, Janssen HL, Reesink HW. Sustained virologic response after therapy with the HCV protease inhibitor narlaprevir in combination with peginterferon and ribavirin is durable through long-term follow-up. J Viral Hepat. 2013 Apr;20(4):e78-81. doi: 10.1111/jvh.12012. Epub 2013 Jan 7.
PubMed 23490393
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1 (Protocol No. P04695)
- ClinicalTrials.gov ID
- NCT01081158
- Acronym / sponsor ID
- P04695
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Mar 2010 (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.
Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCH 900518 in Naive or Treatment-Experienced Subjects Infected With Hepatitis C Virus Genotype 1 (Protocol No. P04695)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment-naïve 800 mg TID | Experimental | Drug: Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron)Period 1: SCH 900518 (800 mg TID) or placebo for 7 days Period 2: SCH 900518 (800 mg TID) + PegIntron (1.5 µg/kg QW) or placebo + PegIntron for 14 days. |
| Treatment-experienced: 800 mg TID | Experimental | Drug: Drug: SCH 900518 Biologic: Peginterferon alfa-2bPeriod 1: SCH 900518 (800 mg TID) or placebo for 7 days Period 2: SCH 900518 (800 mg TID) + PegIntron (1.5 ug/kg QW) or placebo + PegIntron for 14 days |
| Treatment-naïve: 400 mg + RTV BID | Experimental | Drug: Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)Period 1: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) for 7 days. Period 2: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) +PegIntron (1.5 µg/kg QW) for 14 days. |
| Treatment-experienced: 400 mg + RTV BID | Experimental | Drug: Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)Period 1: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) for 7 days. Period 2: SCH 900518 (400 mg BID) or placebo + RTV (200 mg BID) +PegIntron (1.5 µg/kg QW) for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject infected with HCV genotype 1 (any sub-type) virus who is:
- Subject with acceptable medical history, physical examination, and clinical laboratory evaluations consistent with CHC, compensated liver disease, and any associated diseases (diabetes, hypertension, etc).
- Subjects with an HCV RNA viral load of >10^5 copies/mL or equivalent international units
- BMI of 18 to 40 kg/m^2, men and women, ages 18-65 years inclusive
- Female must be non-lactating and have a negative pregnancy test at Screening and Day -1 and either be of nonchildbearing potential or if of childbearing potential, must be practicing effective double-barrier contraceptive methods from at least 2 weeks prior to Day -1 until 30 days after study completion.
Key exclusion criteria (21 listed)
- Subject has a significant acute or chronic medical illness which is not stable or is not controlled with medication (excluding prohibited medications).
- Subject has received an organ transplant.
- Subject has evidence of decompensated liver disease by physical exam (encephalopathy, ascites, caput medusae, etc).
- Subject has at anytime received an HCV NS3-specific protease inhibitor.
- Subject has a platelet count <80,000/mm^3 (confirmed by repeat analysis) at 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 |
|---|---|---|
| Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron)Also: narlaprevir, PegIntronDrug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron) Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days . Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly. | Drug | Treatment-naïve 800 mg TID |
| Drug: SCH 900518 Biologic: Peginterferon alfa-2bAlso: narlaprevir, PegIntronDrug: SCH 900518 Biologic: Peginterferon alfa-2b Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly. | Drug | Treatment-experienced: 800 mg TID |
| Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)Also: narlaprevir, norvir, PegIntronDrug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron) Period 1: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension + ritonavir (200 mg BID) (2-100 mg oral capsules) for 7 days. Period 2: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension+ ritonavir (200 mg BID) (2-100 mg oral capsules) + PegIntron (1.5 µg/kg QW) for 14 days. | Drug | Treatment-naïve: 400 mg + RTV BID |
| Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)Also: narlaprevir, norvir, PegIntronDrug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron) Period 1, Amorphous SCH 900518 (400 mg) or placebo BID administered as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) for 7 days. Period 2, SCH 900518 (400 mg) or placebo BID as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) +PegIntron (1.5 µg/kg SC QW) for 14 days. | Drug | Treatment-experienced: 400 mg + RTV BID |
Primary outcome
Safety and tolerability were to be assessed by collecting adverse events (AEs), vital signs, electrocardiograms (ECGs), physical examinations, urinalysis, and safety laboratory tests.
Time frame: Screening Period: 90 days, Period 1: 7 days, Washout: 4 weeks, Period 2: 14 days, Standard of Care with PegIntron and ribavirin: 84 days
1 secondary outcome
Log change in HCV-RNA from baseline. Ctrough of SCH 900518 resulting in mean HCV RNA decrease > 2 log10 IU/mL. Ctrough of SCH 900518+PEG resulting in HCV-RNA < LOQ. SCH 900518 PK: Cmax, Tmax, AUC, Ctrough, t½, R, CL/F, Vd/F. PEG and RTV: Ctrough
Time frame: Period 1: 7 days, Washout: 4 weeks, Period 2: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Results publication: PubMed 20938912de Bruijne J, Bergmann JF, Reesink HW, Weegink CJ, Molenkamp R, Schinkel J, Tong X, Li J, Treitel MA, Hughes EA, van Lier JJ, van Vliet AA, Janssen HL, de Knegt RJ. Antiviral activity of narlaprevir combined with ritonavir and pegylated interferon in chronic hepatitis C patients. Hepatology. 2010 Nov;52(5):1590-9. doi: 10.1002/hep.23899.
- Results publication: PubMed 23490393Hotho DM, de Bruijne J, Spaan M, Treitel MA, Boonstra A, de Knegt RJ, Janssen HL, Reesink HW. Sustained virologic response after therapy with the HCV protease inhibitor narlaprevir in combination with peginterferon and ribavirin is durable through long-term follow-up. J Viral Hepat. 2013 Apr;20(4):e78-81. doi: 10.1111/jvh.12012. Epub 2013 Jan 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron), Drug: SCH 900518 Biologic: Peginterferon alfa-2b and Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
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 11 inclusion and 21 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 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability were to be assessed by collecting adverse events (AEs), vital signs, electrocardiograms (ECGs), physical examinations, urinalysis, and safety laboratory tests. (time frame: Screening Period: 90 days, Period 1: 7 days, Washout: 4 weeks, Period 2: 14 days, Standard of Care with PegIntron and ribavirin: 84 days). 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 NCT01081158, 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 9 Feb 2015.