Chronic Hepatitis C, Genotype 1Phase 4TTG1NCT00910975
Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C
A Phase 4 study testing Peg-interferon-alfa2a (Pegasys) and Ribavirin (Copegus) in people with Chronic Hepatitis C, Genotype 1, run by Göteborg University at 1 site in Sweden.
Trial summary
The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Genotype 1
- What is being tested?
- Peg-interferon-alfa2a (Pegasys) and Ribavirin (Copegus)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2007to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anti-HCV positive for > 6 months
- Genotype 1
- Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
- Negative pregnancy test (for fertile women)
Who cannot join
- Pregnancy or breast-feeding
- Antiviral or immune modulating treatment the last 6 months
- Hepatitis B or HIV infection (HBsAg, anti-HIV)
- Other significant chronic liver disease
- History of bleeding esophageal varices or other signs of decompensation
- Neutrophiles < 1.0 x 109/L or platelets < 50 x 109/L. S-creatinine > 2 x ULN
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- History of severe psychiatric disorder
- Autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
- Drug abuse, current or during the last year
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 41346
About this study
Official title: Tailored Treatment of Hepatitis C Genotype 1
The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.
Read the detailed description
The current standard regimen for patients with chronic hepatitis C virus (HCV) infection, i.e., 48 weeks of pegylated interferon and ribavirin, needs to be further improved because of high costs and side-effects; in addition, the treatment is curative in only 50% of patients with genotype 1 of HCV. According to the current guidelines treatment with pegylated interferon and ribavirin is given for 24, 48 or 72 weeks depending on the time point when HCV-RNA becomes undetectable (week 4, 12 or 24). Patients with a very poor response may also be identified by applying a stopping rule at week 12 and 24. Still, most patients are treated for 48 weeks and a substantial number of those relapse after discontinuation.
In this study, standard treatment is compared with "tailored treatment", when the treatment duration is based on the time point when HCV RNA level is calculated to be 1 copy/mL, according measurements of HCV RNA on day 14, 21, 28 and 49. This arm also includes an earlier stopping rule: If the HCV RNA does not decline significantly between day 14 and 28, treatment is stopped after 5 weeks.
The advantage of tailored treatment is hypothesised to be that unnecessary side-effects and costs are avoided by an earlier identification of non-response and a treatment duration that is optimised for each patient.
- Conditions
- Chronic Hepatitis C, Genotype 1
- Being tested
- Peg-interferon-alfa2a (Pegasys), Ribavirin (Copegus)
- Keywords
- Hepatitis C virus, Real-time PCR, Treatment
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-interferon-alfa2a (Pegasys)Drug
Also called Pegasys
Peg-interferon-alfa2a 180 µg per week
Ribavirin (Copegus)Drug
Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment is given for 24, 48 or 72 weeks depending on the time point (week 4, 12 or 24) when HCV RNA becomes undetectable by the Cobas Taqman assay. If HCV RNA has not declined 2 logs by week 12 or is detectable at week 24, treatment is stopped. Receives: Drug: Peg-interferon-alfa2a (Pegasys); Drug: Ribavirin (Copegus) |
| Tailored treatment | Experimental | Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment duration is flexible, 24-72 weeks, depending on the time point when the HCV RNA level is calculated to be 1 copy/mL. If the decline between day 14 and 28 is poor, treatment is stopped after 5 weeks. Receives: Drug: Peg-interferon-alfa2a (Pegasys); Drug: Ribavirin (Copegus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication dose per cured patient
Measured: 26 weeks after end of treatment
Secondary outcomes (1)
Sustained virological response and relapse rate
Measured: 26 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startNov 2007
- Primary completionJun 2010
- Study completionSep 2011
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 Chronic Hepatitis C, Genotype 1Studies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Sodra Alvsborgs Hospital, Skaraborg Hospital, Uddevalla Hospital, Skane University Hospital, Lund University Hospital, Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Magnus Lindh, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910975
- Sponsor's protocol ID
- TTG1_081119
- Acronym
- TTG1
- Status last verified
- Sep 2012
- First submitted
- 28 May 2009
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lindh M, Alestig E, Arnholm B, Eilard A, Hellstrand K, Lagging M, Wahlberg T, Wejstal R, Westin J, Norkrans G. Response prediction and treatment tailoring for chronic hepatitis C virus genotype 1 infection. J Clin Microbiol. 2007 Aug;45(8):2439-45. doi: 10.1128/JCM.00577-07. Epub 2007 Jun 20.
PubMed 17581934
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Treatment of Hepatitis C Genotype 1
- ClinicalTrials.gov ID
- NCT00910975
- Acronym / sponsor ID
- TTG1 / TTG1_081119
- Conditions
- Chronic Hepatitis C, Genotype 1
- Keywords
- Hepatitis C virus, Real-time PCR, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Sodra Alvsborgs Hospital, Skaraborg Hospital, Uddevalla Hospital, Skane University Hospital, Lund University Hospital, Karolinska University Hospital
- Study start
- Nov 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Jun 2009 (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.
The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.
Detailed description
The current standard regimen for patients with chronic hepatitis C virus (HCV) infection, i.e., 48 weeks of pegylated interferon and ribavirin, needs to be further improved because of high costs and side-effects; in addition, the treatment is curative in only 50% of patients with genotype 1 of HCV. According to the current guidelines treatment with pegylated interferon and ribavirin is given for 24, 48 or 72 weeks depending on the time point when HCV-RNA becomes undetectable (week 4, 12 or 24). Patients with a very poor response may also be identified by applying a stopping rule at week 12 and 24. Still, most patients are treated for 48 weeks and a substantial number of those relapse after discontinuation.
In this study, standard treatment is compared with "tailored treatment", when the treatment duration is based on the time point when HCV RNA level is calculated to be 1 copy/mL, according measurements of HCV RNA on day 14, 21, 28 and 49. This arm also includes an earlier stopping rule: If the HCV RNA does not decline significantly between day 14 and 28, treatment is stopped after 5 weeks.
The advantage of tailored treatment is hypothesised to be that unnecessary side-effects and costs are avoided by an earlier identification of non-response and a treatment duration that is optimised for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Peg-interferon-alfa2a (Pegasys), Drug: Ribavirin (Copegus)Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment is given for 24, 48 or 72 weeks depending on the time point (week 4, 12 or 24) when HCV RNA becomes undetectable by the Cobas Taqman assay. If HCV RNA has not declined 2 logs by week 12 or is detectable at week 24, treatment is stopped. |
| Tailored treatment | Experimental | Drug: Peg-interferon-alfa2a (Pegasys), Drug: Ribavirin (Copegus)Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment duration is flexible, 24-72 weeks, depending on the time point when the HCV RNA level is calculated to be 1 copy/mL. If the decline between day 14 and 28 is poor, treatment is stopped after 5 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)
- Anti-HCV positive for > 6 months
- Genotype 1
- Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
- Negative pregnancy test (for fertile women)
Key exclusion criteria (9 listed)
- Pregnancy or breast-feeding
- Antiviral or immune modulating treatment the last 6 months
- Hepatitis B or HIV infection (HBsAg, anti-HIV)
- Other significant chronic liver disease
- History of bleeding esophageal varices or other signs of decompensation
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 |
|---|---|---|
| Peg-interferon-alfa2a (Pegasys)Also: PegasysPeg-interferon-alfa2a 180 µg per week | Drug | Standard of care, Tailored treatment |
| Ribavirin (Copegus)Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg | Drug | Standard of care, Tailored treatment |
Primary outcome
Medication dose per cured patient
Time frame: 26 weeks after end of treatment
1 secondary outcome
Sustained virological response and relapse rate
Time frame: 26 weeks after end of treatment
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 5 Sep 2012.
- Background: PubMed 17581934Lindh M, Alestig E, Arnholm B, Eilard A, Hellstrand K, Lagging M, Wahlberg T, Wejstal R, Westin J, Norkrans G. Response prediction and treatment tailoring for chronic hepatitis C virus genotype 1 infection. J Clin Microbiol. 2007 Aug;45(8):2439-45. doi: 10.1128/JCM.00577-07. Epub 2007 Jun 20.
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.
Magnus Lindh, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peg-interferon-alfa2a (Pegasys) and Ribavirin (Copegus) in people with Chronic Hepatitis C, Genotype 1, run by Göteborg University at 1 site in Sweden.
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 9 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 5 Sep 2012. 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 Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Medication dose per cured patient (time frame: 26 weeks after end of treatment). 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 NCT00910975, 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 5 Sep 2012.