Hepatitis C, ChronicSTANDARTNCT01609049
An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 57 sites in 2 countries.
Trial summary
This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine
- How many people
- 1,496 participants
- Where
- 57 sitesin 2 countries
- Study dates
- 7 Dec 2011to 22 Jun 2015
- Phase
- Observational
- 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
Study population: Participants with chronic hepatitis C and compensated liver cirrhosis (Class A by Child-Pugh scale) initiating treatment with Peginterferon alfa-2a and ribavirin
Who may be able to join
- Serologically confirmed chronic hepatitis C (CHC), hepatitis C virus (HCV) RNA detectable
- Compensated liver cirrhosis (Child-Pugh Class A) included
- Initiating combined therapy with peginterferon alfa-2a and ribavirin
Who cannot join
- Human immunodeficiency virus (HIV) co-infection
- Contraindications for combined therapy according to actual prescribing information
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
Russia56 sites
Altay Region Aids Center
Barnaul, 656010
Barnaul City Hospital #5; Therapy
Barnaul, 656045
Chelyabinsk State Medical Academy; Infectious Diseases
Chelyabinsk, 454052
Chita State Medical Academy
Chita, 672090
Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
Irkutsk, 664047
Kaluga regional AIDS center
Kaluga, 248023
Kazan State Medical University
Kazan', 420012
Kemerovo City Infectious Clinical Hospital; Infectious
Kemerovo, 650036
Khabarovsk-1 Road Clinical Hospital; Gastroenterology
Khabarovsk, 680022
Aids Center; Infectious
Khabarovsk, 680031
Kirov Region Aids-Center; Infectious
Kirov, 610000
Clinical Center for the Prevention and Control of AIDS and Infectious Diseases
Krasnodar, 350015
Specialized clinical infectious hospital
Krasnodar, 350015
Region Cinical Hospital; Gastroenterology
Krasnoyarsk, 660022
Krasnoyarsk Region Aids Center; Hepatology
Krasnoyarsk, 660049
Lipetsk Region Aids Center
Lipetsk, 398043
The scientific-research institute of epidemiology
Moscow, 111123
Central Medicosanitary Dept #165
Moscow, 115201
Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases
Moscow, 117292
Central Clinical Hospital of RAS ; HEPATOLOGY
Moscow, 117333
FGBU "Polyclinic #1 Administration President RF
Moscow, 119002
I.M. Sechenov First Moscow State Medical University, The V.H.Vasilenko Clinic
Moscow, 119881
I.M. Sechenov First Moscow State Medical University: The E.M. Tareyev Clinic
Moscow, 119992
Hosital of Infectious Disease #1
Moscow, 123367
State Medical Stomatological Uni ; Infectious
Moscow, 123367
Russian Medical Academy of Postgraduate Education on Botkin S.P. ; City Clinical Hospital
Moscow, 125101
City Hospital # 24; Hepatology
Moscow, 127009
Clinical hospital Centrosouz
Moscow, 129110
3-D Military Clinical Hospital
Moscow, 143420
Medelitconsulting; Medical
Moscow
AIDS Center
Nizniy Novgorod, 603005
Infections Deseases Hospital #1
Novosibirsk, 630016
Baranov Republican Hospital
Petrozavodsk, 185019
City Hospital #1 After Semashko N.A.
Rostov-on-Don, 344010
Rostov State Medical Uni ; Infectious Diseases
Rostov-on-Don, 344022
City Hospital #2; Nefrology
Rostov-on-Don, 344029
Ryazan State Medical University Named after I.P.Pavlov
Ryazan, 390011
S.P. Botkin Clinical Infectious Disease Hospital
Saint Petersburg, 191167
Military Medical Academy; Infectious Deseases
Saint Petersburg, 194044
City polyclinic №107
Saint Petersburg, 195030
Research institute of influenza named after I.I.Mechnikov
Saint Petersburg, 197376
St. Petersburg Aids Center; Haepatology
Saint Petersburg, 198103
Samara State Medical Uni ; Hepatogastroenterology
Samara, 443021
MC Gepatolog
Samara, 443100
City Clinical Hospital №2; Infectional diseases department
Saratov, 410028
Saratov Region Aids Center; Infectious Diseases
Saratov, 410040
Stavropol State Medical Academy
Stavropol, 355017
Consulting diagnostic center
Tyumen, 625026
State Medical Uni of Republic Bashkortostan; Infection Diseases
Ufa, 450000
Vladivostok state medical university
Vladivostok, 690002
MUZ City Clinical Infectional Hospital
Vladivostok, 690065
Volgograd Regional Aids Center For Aids and Infectious Diseases T Volgograd
Volgograd, 400040
Regional Clinical Hospital of Infectious Diseases
Voronezh, 394030
Yakutsk City Hospital
Yakutsk, 677019
Ekaterinburg Regional Hospital #1; Gastroenterology
Yekaterinburg, 620102
National Center for Prevention and Control of AIDS and Infectious Diseases
Yoshkar-Ola, 424037
South Korea1 site
Dongnam Inst.of Radiological & Medical Sciences
Busan, 46033
About this study
Official title: Open-label, Multicenter, Non-Comparative, Prospective Observational Study to Evaluate Efficacy and Safety of Combined Ribavirin and Peginterferon Alfa-2a (40 kDa) Therapy in Patients With Chronic Hepatitis C (CHC) or Compensated Liver Cirrhosis in Real Clinical Practice
This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Peginterferon alfa-2a, Ribavirin
- 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.
Peginterferon alfa-2aDrug
Also called Pegasys
Administration of treatment will be according to local recommendation under local labeling.
RibavirinDrug
Also called Copegus
Ribavirin tablets twice daily orally will be administered depending on body weight, according summary product characteristics and prescribing of ribavirin in real clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Chronic Hepatitis C | Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (less than [<] 50 International Units per Milliliter [IU/mL]) 24 Weeks Post Therapy Completion
Measured: Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years)
Secondary outcomes (8)
Percentage of Naive Participants With Sustained Virological Response (SVR)) and Negative HCV RNA (< 50 IU/mL) at Week 4 and 12
Measured: Week 4, 12
Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12
Measured: Week 12
Percentage of Previously Treated Participants With SVR and Decrease in HCV RNA by Greater Than or Equal to (>/=) 2 Logarithm 10 From Baseline at Week 12
Measured: Baseline, Week 12
Percentage of Naive Participants With SVR and Decrease in HCV RNA by >/= 2 Logarithm 10 From Baseline at Week 12
Measured: Baseline, Week 12
Percentage of Previously Treated Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24
Measured: Week 24
Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24
Measured: Week 24
Percentage of Participants With SVR and Dose Reduction of Ribavirin or Peginterferon alfa-2a due to Adverse Event
Measured: Baseline up to approximately 3.5 years
Percentage of Participants With Adverse Events
Measured: Baseline up to approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study start7 Dec 2011
- Primary completion22 Jun 2015
- Study completion22 Jun 2015
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.
- More trials run by Hoffmann-La RocheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609049
- Sponsor's protocol ID
- ML27851
- Acronym
- STANDART
- Status last verified
- Apr 2017
- First submitted
- 29 May 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Non-Comparative, Prospective Observational Study to Evaluate Efficacy and Safety of Combined Ribavirin and Peginterferon Alfa-2a (40 kDa) Therapy in Patients With Chronic Hepatitis C (CHC) or Compensated Liver Cirrhosis in Real Clinical Practice
- ClinicalTrials.gov ID
- NCT01609049
- Acronym / sponsor ID
- STANDART / ML27851
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,496 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2011 (actual)
- Primary completion
- 22 Jun 2015 (actual)
- Study completion
- 22 Jun 2015 (actual)
- First posted
- 31 May 2012 (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.
This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Chronic Hepatitis C | – | Drug: Peginterferon alfa-2a, Drug: RibavirinNaive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic hepatitis C and compensated liver cirrhosis (Class A by Child-Pugh scale) initiating treatment with Peginterferon alfa-2a and ribavirin
Key inclusion criteria (3 listed)
- Serologically confirmed chronic hepatitis C (CHC), hepatitis C virus (HCV) RNA detectable
- Compensated liver cirrhosis (Child-Pugh Class A) included
- Initiating combined therapy with peginterferon alfa-2a and ribavirin
Key exclusion criteria (2 listed)
- Human immunodeficiency virus (HIV) co-infection
- Contraindications for combined therapy according to actual prescribing information
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 |
|---|---|---|
| Peginterferon alfa-2aAlso: PegasysAdministration of treatment will be according to local recommendation under local labeling. | Drug | Participants with Chronic Hepatitis C |
| RibavirinAlso: CopegusRibavirin tablets twice daily orally will be administered depending on body weight, according summary product characteristics and prescribing of ribavirin in real clinical practice. | Drug | Participants with Chronic Hepatitis C |
Primary outcome
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (less than [<] 50 International Units per Milliliter [IU/mL]) 24 Weeks Post Therapy Completion
Time frame: Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years)
8 secondary outcomes
Percentage of Naive Participants With Sustained Virological Response (SVR)) and Negative HCV RNA (< 50 IU/mL) at Week 4 and 12
Time frame: Week 4, 12
Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12
Time frame: Week 12
Percentage of Previously Treated Participants With SVR and Decrease in HCV RNA by Greater Than or Equal to (>/=) 2 Logarithm 10 From Baseline at Week 12
Time frame: Baseline, Week 12
Percentage of Naive Participants With SVR and Decrease in HCV RNA by >/= 2 Logarithm 10 From Baseline at Week 12
Time frame: Baseline, Week 12
Percentage of Previously Treated Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24
Time frame: Week 24
Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24
Time frame: Week 24
Percentage of Participants With SVR and Dose Reduction of Ribavirin or Peginterferon alfa-2a due to Adverse Event
Time frame: Baseline up to approximately 3.5 years
Percentage of Participants With Adverse Events
Time frame: Baseline up to approximately 3.5 years
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 12 Apr 2017.
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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.
Clinical Trials study director
Hoffmann-La Roche
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 57 sites in 2 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 3 inclusion and 2 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 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Russia, South Korea. 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.
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?
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (less than [<] 50 International Units per Milliliter [IU/mL]) 24 Weeks Post Therapy Completion (time frame: Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.