Hepatitis CPhase 4NCT00277862
Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4
A Phase 4 study testing Pegylated IFN- alpha 2b and Ribavirin in people with Hepatitis C, run by Ain Shams University at 4 sites in Egypt.
Trial summary
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Pegylated IFN- alpha 2b and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 4 sitesEgypt
- Study dates
- Apr 2002to Apr 2007
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Previous IFN-alpha therapy; other liver diseases such as hepatitis A, hepatitis B, schistosomiasis, autoimmune hepatitis, alcoholic liver disease, drug induced hepatitis, or decompensated liver disease; coinfection with schistosomiasis or human immunodeficiency virus; neutro¬penia (,1 500/mm3); thrombocytopenia (,90 000/mm3); creatinine concentration .1.5 times the upper limit of normal; serum a fetoprotein concentration .25 ng/ml; organ transplant; neoplastic disease; severe cardiac or pulmonary disease; unstable thyroid dysfunction; psychiatric disorder; current pregnancy or breast feeding; or therapy with immunomodulatory agents within the last six months.
Trial locations and contacts
4 sites in 1 country.
Egypt4 sites
AUS Specialized Hospital,
Cairo, Cairo Governorate, 11351,
DIACSERA
Cairo
MISR Welding
Cairo
ELectricity Auth
Mynia and Cairo
About this study
Official title: Role of Rapid Virologic Response in Determining Treatment Duration of Peginterferon Alfa-2b/Ribavirin in Chronic Hepatitis C Genotype 4
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70%. The duration of treatment has not been accurately defined. The main objective of this is to assess the duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C.
Read the detailed description
Hepatitis C virus (HCV) genotype 4 is the most frequent cause of chronic hepatitis C in Middle East, North Africa and sub-Saharan Africa. In countries like Egypt, 73 to 90% of cases of chronic hepatitis C are caused by genotype 4. Recently, epidemiological reports showed spread of HCV-4 infection in Western countries such as France, Italy, Greece, Spain and the United States particularly among intravenous drug users.
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70%. We have previously shown that, treatment patients with chronic HVCG4with PEG-IFN α-2b plus ribavirin for 36 or 48 weeks was more effective (SVR 66% and 69%, respectively) than for 24 weeks.
It has been shown in previous studies on chronic hepatitis C genotype 1 that individuals who achieve an early virologic have a higher chance to achieve a sustained virologic response. Peg interferon and ribavirin therapy is associated with adverse events and is expensive; therefore, careful determination of the optimal treatment duration is crucial as it spares the patient unnecessary or prolonged therapy and enhances the cost-effectiveness of therapy.
Therefore the main objective of this randomized, multicenter trial is to assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C.
- Conditions
- Hepatitis C
- Being tested
- Pegylated IFN- alpha 2b, Ribavirin
- Keywords
- chronic hepatitis C;, peg-interferon alfa-2b;, ribavirin,, rapid virologic response,, sustained virological response
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated IFN- alpha 2bDrug
Also called PEG-IFN alpha-2b, PEG-Intron™
RibavirinDrug
Also called Rebetol, Virin, Ribavrin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 1. Pegylated IFN- alpha 2b
2. Ribavirin for 24 weeks (patients with RVR) Receives: Drug: Pegylated IFN- alpha 2b; Drug: Ribavirin |
| 2 | Active comparator | 1. Pegylated IFN- alpha 2b
2. Ribavirin for 36 weeks (patients with complete EVR) Receives: Drug: Pegylated IFN- alpha 2b; Drug: Ribavirin |
| 3 | Active comparator | 1. Pegylated IFN- alpha 2b
2. Ribavirin for 48 weeks (patients with partial EVR) Receives: Drug: Pegylated IFN- alpha 2b; Drug: Ribavirin |
| 4 | Active comparator | 1. Pegylated IFN- alpha 2b
2. Ribavirin for 48 weeks (control) Receives: Drug: Pegylated IFN- alpha 2b; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained virologic response defined as undetectable serum HCV RNA levels (Amplicor HCV, Roche Molecular Systems; lower limit of detection (LLD) of 50 IU/mL)
Measured: 18 months
Secondary outcomes (2)
Virologic response at the end of treatment (EOT) defined as undetectable HCV RNA serum levels (50 IU/ml) at the end of the scheduled treatment period
Measured: 6-12 months and 6 months follow-up
sustained virologic response (primary) histological response (secondary) biochemical response (secondary)
Measured: 6-12 months treatment), 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startApr 2002
- Primary completionMar 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough, Fulbright, Tempus AI, International Society for Infectious Diseases
- Investigators
- Sanaa M Kamal, M.D.; Ph.D, Principal investigator, AUS Specialized Hospital, Cairo, Cairo, 11351, Egypt;Amany Sayed Ahmad, M.D., Principal investigator, DIAGSERASamer El Kamary, Principal investigator, UMBAmal Abdel Baky, M.D., Principal investigator, DIGSERA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277862
- Sponsor's protocol ID
- G43230832638
- Status last verified
- Feb 2008
- First submitted
- 15 Jan 2006
- Last updated
- 26 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kamal SM, El Tawil AA, Nakano T, He Q, Rasenack J, Hakam SA, Saleh WA, Ismail A, Aziz AA, Madwar MA. Peginterferon alpha-2b and ribavirin therapy in chronic hepatitis C genotype 4: impact of treatment duration and viral kinetics on sustained virological response. Gut. 2005 Jun;54(6):858-66. doi: 10.1136/gut.2004.057182.
PubMed 15888797Kamal SM, Fehr J, Roesler B, Peters T, Rasenack JW. Peginterferon alone or with ribavirin enhances HCV-specific CD4 T-helper 1 responses in patients with chronic hepatitis C. Gastroenterology. 2002 Oct;123(4):1070-83. doi: 10.1053/gast.2002.36045.
PubMed 12360469Kamal SM, El Kamary SS, Shardell MD, Hashem M, Ahmed IN, Muhammadi M, Sayed K, Moustafa A, Hakem SA, Ibrahiem A, Moniem M, Mansour H, Abdelaziz M. Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: The role of rapid and early virologic response. Hepatology. 2007 Dec;46(6):1732-40. doi: 10.1002/hep.21917.
PubMed 17943989
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Rapid Virologic Response in Determining Treatment Duration of Peginterferon Alfa-2b/Ribavirin in Chronic Hepatitis C Genotype 4
- ClinicalTrials.gov ID
- NCT00277862
- Acronym / sponsor ID
- G43230832638
- Conditions
- Hepatitis C
- Keywords
- chronic hepatitis C;, peg-interferon alfa-2b;, ribavirin,, rapid virologic response,, sustained virological response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Schering-Plough, Fulbright, Tempus AI, International Society for Infectious Diseases
- Study start
- Apr 2002
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 18 Jan 2006 (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.
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70%. The duration of treatment has not been accurately defined. The main objective of this is to assess the duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C.
Detailed description
Hepatitis C virus (HCV) genotype 4 is the most frequent cause of chronic hepatitis C in Middle East, North Africa and sub-Saharan Africa. In countries like Egypt, 73 to 90% of cases of chronic hepatitis C are caused by genotype 4. Recently, epidemiological reports showed spread of HCV-4 infection in Western countries such as France, Italy, Greece, Spain and the United States particularly among intravenous drug users.
Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to conventional interferon monotherapy. Recent reports showed that pegylated interferon and ribavirin combination therapy markedly increased the SVR rate to 55-70%. We have previously shown that, treatment patients with chronic HVCG4with PEG-IFN α-2b plus ribavirin for 36 or 48 weeks was more effective (SVR 66% and 69%, respectively) than for 24 weeks.
It has been shown in previous studies on chronic hepatitis C genotype 1 that individuals who achieve an early virologic have a higher chance to achieve a sustained virologic response. Peg interferon and ribavirin therapy is associated with adverse events and is expensive; therefore, careful determination of the optimal treatment duration is crucial as it spares the patient unnecessary or prolonged therapy and enhances the cost-effectiveness of therapy.
Therefore the main objective of this randomized, multicenter trial is to assess the clinical utility of rapid and early virologic response in determining the optimal duration of peg interferon ribavirin therapy in chronic hepatitis C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Pegylated IFN- alpha 2b, Drug: Ribavirin1. Pegylated IFN- alpha 2b 2. Ribavirin for 24 weeks (patients with RVR) |
| 2 | Active comparator | Drug: Pegylated IFN- alpha 2b, Drug: Ribavirin1. Pegylated IFN- alpha 2b 2. Ribavirin for 36 weeks (patients with complete EVR) |
| 3 | Active comparator | Drug: Pegylated IFN- alpha 2b, Drug: Ribavirin1. Pegylated IFN- alpha 2b 2. Ribavirin for 48 weeks (patients with partial EVR) |
| 4 | Active comparator | Drug: Pegylated IFN- alpha 2b, Drug: Ribavirin1. Pegylated IFN- alpha 2b 2. Ribavirin for 48 weeks (control) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Previous IFN-alpha therapy; other liver diseases such as hepatitis A, hepatitis B, schistosomiasis, autoimmune hepatitis, alcoholic liver disease, drug induced hepatitis, or decompensated liver disease; coinfection with schistosomiasis or human immunodeficiency virus; neutro¬penia (,1 500/mm3); thrombocytopenia (,90 000/mm3); creatinine concentration .1.5 times the upper limit of normal; serum a fetoprotein concentration .25 ng/ml; organ transplant; neoplastic disease; severe cardiac or pulmonary disease; unstable thyroid dysfunction; psychiatric disorder; current pregnancy or breast feeding; or therapy with immunomodulatory agents within the last six months.
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 |
|---|---|---|
| Pegylated IFN- alpha 2bAlso: PEG-IFN alpha-2b, PEG-Intron™ | Drug | 1, 2, 3, 4 |
| RibavirinAlso: Rebetol, Virin, Ribavrin | Drug | 1, 2, 3, 4 |
Primary outcome
sustained virologic response defined as undetectable serum HCV RNA levels (Amplicor HCV, Roche Molecular Systems; lower limit of detection (LLD) of 50 IU/mL)
Time frame: 18 months
2 secondary outcomes
Virologic response at the end of treatment (EOT) defined as undetectable HCV RNA serum levels (50 IU/ml) at the end of the scheduled treatment period
Time frame: 6-12 months and 6 months follow-up
sustained virologic response (primary) histological response (secondary) biochemical response (secondary)
Time frame: 6-12 months treatment), 6 months follow-up
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 26 Feb 2008.
- Background: PubMed 15888797Kamal SM, El Tawil AA, Nakano T, He Q, Rasenack J, Hakam SA, Saleh WA, Ismail A, Aziz AA, Madwar MA. Peginterferon alpha-2b and ribavirin therapy in chronic hepatitis C genotype 4: impact of treatment duration and viral kinetics on sustained virological response. Gut. 2005 Jun;54(6):858-66. doi: 10.1136/gut.2004.057182.
- Background: PubMed 12360469Kamal SM, Fehr J, Roesler B, Peters T, Rasenack JW. Peginterferon alone or with ribavirin enhances HCV-specific CD4 T-helper 1 responses in patients with chronic hepatitis C. Gastroenterology. 2002 Oct;123(4):1070-83. doi: 10.1053/gast.2002.36045.
- Derived from this study: PubMed 17943989Kamal SM, El Kamary SS, Shardell MD, Hashem M, Ahmed IN, Muhammadi M, Sayed K, Moustafa A, Hakem SA, Ibrahiem A, Moniem M, Mansour H, Abdelaziz M. Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: The role of rapid and early virologic response. Hepatology. 2007 Dec;46(6):1732-40. doi: 10.1002/hep.21917.
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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.
Sanaa M Kamal, M.D.; Ph.D principal investigator
AUS Specialized Hospital, Cairo, Cairo, 11351, Egypt;
Amany Sayed Ahmad, M.D. principal investigator
DIAGSERA
Samer El Kamary principal investigator
UMB
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pegylated IFN- alpha 2b and Ribavirin in people with Hepatitis C, run by Ain Shams University at 4 sites in Egypt.
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 0 inclusion and 1 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 26 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt. 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?
sustained virologic response defined as undetectable serum HCV RNA levels (Amplicor HCV, Roche Molecular Systems; lower limit of detection (LLD) of 50 IU/mL) (time frame: 18 months). 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 NCT00277862, which also lists 3 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 26 Feb 2008; AzTrials last refreshed its copy on 7 Nov 2026.