A Phase 3 interventional study of sofosbuvir and daclatasvir in Hepatitis C Virus Infection, Response to Therapy of and Human Immunodeficiency Virus, sponsored by Tehran University of Medical Sciences. Completed at 2 sites in Iran, Islamic Republic of. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by Tehran University of Medical Sciences · Phase 3, Interventional, and Treatment
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Among 94 studies testing sofosbuvir in Hepatitis C — 1 open to participants now, 3 under way, none of them phase 3. Sofosbuvir · Hepatitis C.
Among the 94 studies testing sofosbuvir in Hepatitis C, this one is the 20th largest by enrollment, is one of 11 that started in 2017, is one of 30 in phase 3, and was the 69th registered.
1,744 studies on the registry are indexed under Hepatitis C; 98 are open to participants now.
Browse Hepatitis C studies →1 of the 94 studies testing sofosbuvir in Hepatitis C is open now. Recruiting first, the newest first:
Eastern Idaho Public Health
Ages 18+
Sofosbuvir: first FDA approval 2013 (SOVALDI), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 56 Hepatitis C studies recruiting now, 43 (77%) set no upper age limit and 6 (11%) stop at 75 or younger; 10 take children under 18; 26 take healthy volunteers.
This study: 12 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
94 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 34 · Phase 3 31 · Phase 4 22
First in 2010; this study’s year is marked. 11 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 232 is above the median of 73 across 1,224 interventional studies indexed under Hepatitis C.
Median enrollment 75 across the 94 interventional studies. Of the 78 that completed or were terminated, 50 (64%) have results posted.
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48 of 94 have an industry lead sponsor. The 10 most frequent:
Tehran University of Medical Sciences is the lead sponsor of 231 studies on the registry; 12 are open to participants now.
Tehran University of Medical Sciences has 7 studies filed under Hepatitis C — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 94 studies testing sofosbuvir in Hepatitis C, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
To achieve the goal of elimination of hepatitis C in 2030 as set forward by the world health organization (WHO) a main group requiring treatment are subjects co-infected with HIV. These subjects offer a particular challenge as they are receiving ART which frequently interferes with hepatitis treatment. The number of pills they are already taking also limits the compliance of these patients.
In order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular ART medicine being used by the patient - a multi-center study of 200 co-infected patients has been designed.
The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.
The study is one of the pilots being run for hepatitis C elimination in Iran.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once daily fixed-dose combination pill of sofosbuvir and daclatasvir for 12 weeks if the patient is non cirrhotic and for 24 weeks if cirrhotic
Drug: sofosbuvir and daclatasvir
Drug pages: Sofosbuvir · Daclatasvir
Depending on the ART received by each patient one of the fixed-dose combination pills below will be used: 1. Daclatasvir 30 mg and sofosbuvir 400 mg 2. Daclatasvir 60 mg and sofosbuvir 400 mg 3. Daclatasvir 90 mg and sofosbuvir 400 mg
Also known as: Sovodak 30/400, Sovodak 60/400, Sovodak 90/400
The sustained viral response rate
Qualitative hepatitis C virus RNA polymerase chain reaction
Time frame: 12 weeks after end of treatment
Adverse drug events
Questionnaire
Time frame: weeks 2, 4, 8, 12 and 24
Plan to share: No
Ran from Jan 2017 to primary completion in Sep 2018, 20 months.
Of 90 phase 3 interventional studies under Hepatitis C, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 22. This study's 20 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sofosbuvir · Daclatasvir
Tehran University of Medical Sciences →