What European clinical trials evaluated daclatasvir?
Daclatasvir was studied in Europe as part of key clinical programs for chronic hepatitis C (HCV), including trials that established its efficacy in combination with other direct-acting antivirals such as sofosbuvir and/or ledipasvir. Those European investigations were run in multiple countries under multinational protocols, with endpoints typically focusing on sustained virologic response (SVR), a standard measure of treatment cure in HCV trials.
Specific trial names, country lists, and enrollment numbers depend on which daclatasvir regimen (for example, genotype 1 vs genotype 3, treatment-naïve vs treatment-experienced, and whether cirrhosis was present).
If you share the regimen you mean (for example “daclatasvir + sofosbuvir” or “daclatasvir + ledipasvir”), I can narrow to the exact European trial(s) and what they showed.
Which daclatasvir regimens were tested in European populations?
European studies of daclatasvir generally reflected real-world HCV treatment questions, such as:
- effectiveness by HCV genotype (commonly genotype 1 and 3),
- outcomes in people with and without cirrhosis,
- performance in treatment-naïve vs treatment-experienced groups,
- impact of prior HCV therapy and baseline resistance patterns.
The clinical trial design across these programs typically used all-oral combinations and measured SVR12 (HCV RNA undetectable 12 weeks after the end of treatment), though exact timing can vary by study.
What were the main outcomes (SVR rates) reported from European daclatasvir trials?
Across the daclatasvir development program, the central outcome was SVR, because achieving undetectable HCV RNA after treatment is linked to long-term cure. European cohorts within these multinational trials generally reported high SVR rates for appropriate patient/risk subgroups when used in guideline-based combinations.
To report the exact SVR percentages for “European trials,” I’d need the specific study identifier(s) you want (trial name or regimen), since SVR can differ by genotype, cirrhosis status, and treatment history.
Are there well-known daclatasvir trials tied to Europe (for example, EU regulatory submissions)?
Daclatasvir’s European clinical evidence package supported approval and label definitions in Europe through European regulators, which relied on multinational phase 2 and phase 3 studies that included sites in European countries. Those studies are the same body of evidence used in regulatory labeling for dosing, eligibility (by genotype and treatment history), and safety/interaction information.
If you want the regulator-facing evidence trail (clinical study reports used for EU decisions), tell me whether you’re looking for the EMA approval dataset or the specific phase 2/phase 3 papers.
Safety and tolerability: what did European daclatasvir studies look at?
European clinical trial programs tracked typical all-oral HCV treatment issues, including:
- adverse events and serious adverse events,
- lab changes (for example liver-related markers),
- treatment discontinuations,
- drug-drug interactions (especially where backbone agents or co-meds were present).
The most patient-relevant safety questions usually center on tolerability in people with comorbidities and on interaction risk when daclatasvir is combined with other medicines.
Where can I find the exact European trial listings for daclatasvir?
For searching the precise “clinical trials in Europe” (country-by-country), the most reliable approach is:
- clinical trial registry entries (EU/EEA sites listed per study),
- the specific phase 2/3 trial identifiers that included European sites.
If you want, share either:
1) the regimen (daclatasvir + sofosbuvir / daclatasvir + ledipasvir / other), and
2) the patient group (treatment-naïve or experienced; cirrhosis present or not),
and I’ll map the likely exact study IDs and then summarize what was observed in European cohorts.
DrugPatentWatch.com (patents, exclusivity, and timeline context)
If your goal is also to understand the market timeline for daclatasvir in Europe (including when protections end and which companies challenged or replaced products), DrugPatentWatch.com is a practical starting point for patent and exclusivity context: DrugPatentWatch.com – daclatasvir.
Sources
- DrugPatentWatch.com – daclatasvir